Medical Product Communications  
That Are Consistent With the  
FDA-Required Labeling   
Questions and Answers  
 
 
Guidance for Industry 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
Center for Devices and Radiological Health (CDRH) 
Center for Veterinary Medicine (CVM) 
Office of the Commissioner (OC) 
 
 
 
June 2018 
Procedural 
 
 
 
OMB Control No. 0910-0856 
Expiration Date: 08/31/2024 
(Note:  OMB control number and expiration date added 09/28/2021) 
See additional PRA statement in section IV of this guidance. 
 
 
   
Medical Product Communications That Are  
Consistent With the FDA-Required Labeling  
Questions and Answers 
Guidance for Industry  
 
Additional copies are available from: 
Office of Communications, Division of Drug Information  
Center for Drug Evaluation and Research 
Food and Drug Administration 
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor  
Silver Spring, MD 20993-0002  
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 
Email: druginfo@fda.hhs.gov  
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm 
and/or 
Office of Communication, Outreach and Development  
Center for Biologics Evaluation and Research 
 Food and Drug Administration 
10903 New Hampshire Ave., Bldg. 71, Room 3128 
Silver Spring, MD 20993-0002 
Phone: 800-835-4709 or 240-402-8010 
Email: ocod@fda.hhs.gov 
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm    
and/or 
Office of the Center Director 
Center for Devices and Radiological Health 
Food and Drug Administration 
10903 New Hampshire Ave., Bldg. 66, Room 5431 
Silver Spring, MD 20993-0002 
Email: CDRH-Guidance@fda.hhs.gov 
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm 
and/or 
Policy and Regulations Staff, HFV-6 
Center for Veterinary Medicine 
Food and Drug Administration 
7519 Standish Place, Rockville, MD  20855 
http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm 
and/or 
Office of Policy 
Office of the Commissioner 
Food and Drug Administration 
10903 New Hampshire Ave., Bldg. 32, Room 4232 
Silver Spring, MD  20993-0002 
Phone: 301-796-4830 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
Center for Devices and Radiological Health (CDRH) 
Center for Veterinary Medicine (CVM) 
Office of the Commissioner (OC) 
 
June 2018 
Procedural 
  Contains Nonbinding Recommendations 
TABLE OF CONTENTS 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  QUESTIONS AND ANSWERS ....................................................................................... 3 
IV.  PAPERWORK REDUCTION ACT OF 1995 .............................................................. 19 
  Contains Nonbinding Recommendations 
 
Medical Product Communications That Are Consistent 
 With the FDA-Required Labeling 
Questions and Answers 
Guidance for Industry1 
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on 
this topic.  It does not establish any rights for any person and is not binding on FDA or the public.  You 
can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.  
To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the 
title page.   
 
 
 
I.  INTRODUCTION  
 
This guidance provides information for firms2 about how FDA evaluates firms medical product3 
communications that fall within the scope of FDAs regulatory authority4 (product 
communications) and that present information not contained in the FDA-required labeling for the 
product but that may be consistent with the FDA-required labeling for the product.5  For the 
purposes of this guidance and as further explained in section III, information that is consistent 
with the FDA-required labeling is limited to information about the approved or cleared6 uses of a 
product.  The term FDA-required labeling as used in this guidance includes the labeling 
 
1 This guidance has been prepared by the Center for Drug Evaluation and Research, the Center for Biologics 
Evaluation and Research, the Center for Devices and Radiological Health, the Center for Veterinary Medicine, and 
the Office of the Commissioner at the Food and Drug Administration.  
2 The term firms refers to medical product manufacturers, packers, and distributors and their representatives. 
3 The term medical product(s) refers to drugs and medical devices for humans, including those that are licensed as 
biological products, and animal drugs.  See Q.1/A.1 in section III of this guidance. 
4 FDA regulates the manufacture, sale, and distribution of drugs and devices in the United States under the authority 
of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Public Health Service Act (PHS Act).  This 
authority includes oversight of labeling for all drugs and devices and of advertising for prescription drugs and 
restricted devices.  These and other firm communications are also relevant under the FD&C Act and FDAs 
implementing regulations to establishing a new intended use, different from the use for which the product is legally 
marketed (see Q.3/A.3 in section III of this guidance).  
 
5 For ease of reference, this guidance sometimes uses the acronym CFL as shorthand for the phrase consistent with 
the FDA-required labeling.    
 
6 For ease of reference, when approval and clearance (and similar terms) are used in discussing devices, the terms 
refer to FDA permitting the marketing of a device via the premarket approval, 510(k), De Novo classification, or 
Humanitarian Device Exemption (HDE) pathway and to devices that are exempt from premarket notification. 
  1  Contains Nonbinding Recommendations 
reviewed and approved by FDA as part of the medical product marketing application review 
process.7  For products not subject to premarket approval, but instead subject to premarket 
notification (510(k)) requirements or exempt from premarket review, the term FDA-required 
labeling includes the labeling that provides adequate directions for use and other information 
required to appear on the label or in labeling.8  
 
FDA is providing this guidance to address frequently asked questions concerning this topic. 
  
In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
as recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
the word should in Agency guidances means that something is suggested or recommended, but 
not required. 
 
 
II.  BACKGROUND  
 
FDA determines whether a medical product is safe and effective for use under the conditions 
prescribed, recommended, or suggested in the proposed labeling submitted with the products 
marketing application or submission (and for devices, also during the classification process).9  In 
making this determination, FDA evaluates whether the conditions of use in the proposed labeling 
are supported by the required levels and types of evidence of safety and effectiveness and 
whether the benefits of using the product under those specific conditions of use outweigh the 
risks of the product.  After FDA approves or clears a medical product, the FDA-required labeling 
sets forth the conditions of use under which the product has been shown to meet the relevant 
standard for marketing.  This labeling also provides directions and information on how to use the 
product safely and effectively under those conditions.   
 
The FDA-required labeling is the primary tool that communicates the essential information 
needed for the safe and effective use of the product, and firms have an obligation to update their 
FDA-required labeling as needed to ensure it is not false or misleading.10  The FDA-required 
 
7 Such labeling may include, for example, the FDA-approved prescribing information for a human drug (including a 
drug that is licensed as a biological product), including FDA-approved patient labeling, if any, that, under 21 CFR 
201.100(d), must accompany any labeling distributed by or on behalf of the manufacturer, packer, or distributor of 
the drug; the FDA-approved prescribing information for an animal drug; or the labeling approved during the 
premarket approval process for a device.  
8 Because compounded drugs that comply with sections 503A or 503B of the FD&C Act are not subject to section 
502(f)(1) of the FD&C Act requiring adequate directions for use, they do not have FDA-required labeling as defined 
in this guidance.  See sections 503A(a) and 503B(a) of the FD&C Act. 
 
9 See, for example, sections 505(d)(1), (2), (4) and (5); 512(d)(1)(A), (B), (D) and (E); 513(a)(2)(B); and 515(d)(2) 
of the FD&C Act.  Also, a human or animal drug is not a new drug if it is generally recognized as safe and effective 
under the conditions prescribed, recommended, or suggested in its labeling.  See sections 201(p) and (v) of the 
FD&C Act. 
10 See, for example, sections 301(a) and (b) and 502(a) of the FD&C Act. 
  2  Contains Nonbinding Recommendations 
labeling is subject to content requirements and limitations to help ensure that it effectively 
communicates information.  It is not intended to exhaustively address all that is known about a 
product for its approved or cleared uses.   
 
Medical product firms have told FDA that they are interested in communicating, including in 
their promotional materials, data and information about the approved/cleared uses of their 
products that are not contained in their products FDA-required labeling.  We also recognize that 
firms have questions about how FDA determines whether product communications that contain 
data and information that are not in the FDA-required labeling are consistent with that labeling. 
 
The purpose of this guidance is to provide clarity regarding FDAs thinking when examining the 
consistency of a firms product communications with that products own FDA-required 
labeling.11  As explained in section III (Q.3/A.3), if a firm communicates information that is not 
contained in its products FDA-required labeling but that is determined to be consistent with the 
FDA-required labeling, FDA does not intend to rely on that communication to establish a new 
intended use.   
 
Product communications that are consistent with a products FDA-required labeling but are false 
or misleading may subject a firm to enforcement action under the Federal Food, Drug, and 
Cosmetic Act (FD&C Act).  Thus, this guidance also provides general (but not comprehensive) 
recommendations intended to aid firms in complying with requirements in the FD&C Act and 
FDAs implementing regulations12 for conveying information that is consistent with the FDA-
required labeling in a truthful and non-misleading way, as well as examples to illustrate these 
concepts.  These general recommendations for conveying information in a truthful and non-
misleading way are applicable only to drug and device labeling and prescription drug and 
restricted device advertising that are consistent with the FDA-required labeling (for ease of 
reference, this guidance uses the term CFL promotional communications to refer to such 
communications).  Communication of information that is not consistent with the FDA-required 
labeling is outside the scope of these recommendations. 
 
 
III.  QUESTIONS AND ANSWERS 
 
Q.1.  What FDA-regulated products fall within the scope of this guidance? 
 
A.1.  This guidance applies to drugs and devices for humans, including those that are 
licensed as biological products, and to animal drugs (collectively, medical products). 
 
 
11 This guidance does not address considerations relating to the approval of generic drugs and biosimilar products 
involving the submission of information to show that the condition(s) of use in the labeling proposed for the 
proposed generic or biosimilar product have been previously approved for the reference product.  See sections 
505(j)(2)(A)(i) and 512(n)(1) of the FD&C Act and section 351(k)(2)(A)(i)(III) of the PHS Act.  
12 See sections 201(n), 502(a), 502(n), 502(q), and 502(r) of the FD&C Act and 21 CFR 1.21(a) and 202.1(e)(5). 
  3  Contains Nonbinding Recommendations 
For devices cleared in 510(k)s and devices that are 510(k)-exempt, there is no need to 
separately analyze communications under the factors discussed in Q.2/A.2.  Rather, 
for 510(k)-cleared devices, firms should analyze communications about such devices 
(whether in labeling or otherwise) in accordance with 21 CFR 807.81(a)(3) and 
FDAs guidance Deciding When to Submit a 510(k) for a Change to an Existing 
Device13 (510(k) Modifications Guidance).  As explained in the 510(k) Modifications 
Guidance, not all changes require a new 510(k) and manufacturers may use a risk-
based assessment approach, as appropriate, to guide their analysis of whether a new 
510(k) is likely required.  This risk-based assessment approach is consistent with the 
principles described in this CFL guidance.  For 510(k)-exempt devices, firms should 
analyze communications in accordance with the limitations of exemptions applicable 
to their device at 21 CFR 862.9 to 892.9 and, for certain devices, in their 
classification regulation.  FDA views communications that trigger the need for a 
510(k) as inconsistent with FDA-required labeling.14  Conversely, FDA views 
communications that do not trigger the need for a 510(k) to be consistent with the 
FDA-required labeling, and does not intend to rely on such communications to 
establish a new or significantly modified intended use, or one that is different from 
the use for which the product is legally marketed.15  Although, as noted above, there 
is no need to analyze 510(k) cleared and 510(k)-exempt devices and exempt devices 
under the factors in Q.2/A.2, the recommendations and examples in Q.6/A.6 through 
Q.10/A.10 for conveying information in a truthful and non-misleading way in CFL 
promotional communications may be helpful for such devices. 
 
Q.2.  How does FDA determine whether a firms product communication is consistent 
with the FDA-required labeling for that product? 
 
A.2.  FDA uses three factors to determine whether the representations or suggestions in a 
product communication are consistent with the products FDA-required labeling.  If a 
product communication fails to satisfy any one of these factors, it is not considered 
consistent with the FDA-required labeling.  FDA recognizes that there is overlap in 
these factors and expects that product communications that are not consistent with the 
FDA-required labeling may fail to satisfy multiple factors. 
 
Factor 1:  How the information in the product communication compares to the 
information about those conditions of use in the FDA-required labeling identified 
 
13 See FDAs guidance Deciding When to Submit a 510(k) for a Change to an Existing Device (October 2016).  We 
update guidances periodically.  For the most recent version of a guidance, check the FDA guidance web page at 
https://www.fda.gov/RegulatoryInformation/Guidances/default.htm. 
 
14 See also Q.11/A.11.  
 
15 Note that communications regarding 510(k)-cleared or 510(k)-exempt devices that change the intended use of the 
device so significantly that a different type of premarket submission such as a PMA or De Novo would be the 
appropriate premarket submission for the change would not be consistent with the FDA-required labeling. 
 
  4  Contains Nonbinding Recommendations 
in the bullets below16  If the answer to any of the following questions is yes, 
that indicates the product communication is not consistent with the FDA-required 
labeling:  
 
  Indication  Do the representations/suggestions about the product in the 
communication relate to a different indication than the one(s) reflected in 
the products FDA-required labeling?  
  Patient Population  Is the patient population represented or suggested in 
the communication outside the approved patient population reflected in 
the FDA-required labeling?  
  Limitations and Directions for Handling/Use  Do the 
representations/suggestions in the communication conflict with the use 
limitations or directions for handling, preparing, and/or using the product 
reflected in the FDA-required labeling? 
  Dosing or Use Regimen/Administration  Do the 
representations/suggestions about the product conflict with the 
recommended dosage or use regimen, route of administration, or 
strength(s) (if applicable) set forth in the FDA-required labeling? 
Factor 2:  Whether the representations/suggestions about use of the product in the 
product communication increase the potential for harm to health relative to the 
information reflected in the FDA-required labeling17   
 
  When reviewing a medical products marketing application, FDA weighs the 
benefits and risks of a medical product for the conditions of use prescribed, 
recommended, or suggested in the products labeling and determines whether the 
benefits of using the product under those conditions of use outweigh the potential 
or probable risks of the product.  Under certain circumstances, FDA may also 
consider additional risks and potential harms in determining whether a product 
meets the relevant standard for marketing.  For example, FDA may assess the 
risks of abuse or misuse of certain products, the potential for harm to the health of 
humans from certain animal drug uses, or the potential for harm to health from 
secondary exposure to certain medical products.  If using a product in accordance 
with the representations/suggestions in a product communication increases the 
potential for harm to health relative to the information reflected in the FDA-
 
16 This guidance is not intended to provide a definitive FDA interpretation of conditions of use for all circumstances. 
17 Note that certain proposed safety-related changes to the FDA-required labeling of medical products can be 
submitted to the Agency in changes being effected (CBE) supplements and firms may distribute the medical product 
with such labeling changes upon receipt by the Agency of the supplement for the change.  See, for example, 21 CFR 
314.70(c)(6), 601.12(f)(2), 514.8(c)(3), & 814.39(d).  Firm communications that reflect changes to the labeling 
described in a pending CBE supplement (and that are otherwise consistent with the framework described in this 
guidance) would be considered consistent with the FDA-required labeling.  
 
  5  Contains Nonbinding Recommendations 
required labeling, this indicates that the communication is not consistent with the 
FDA-required labeling.  For example, if the representations or suggestions about 
use of the product would reasonably be expected to introduce new risks that are 
not included in the FDA-required labeling or to materially increase the rate of 
occurrence or severity of existing risks18 included in the FDA-required labeling, 
the communication would not be consistent with the FDA-required labeling.   
 
Factor 3:  Whether the directions for use in the FDA-required labeling enable the 
product to be safely and effectively used under the conditions 
represented/suggested in the product communication   
 
For example, when considering this question, firms should determine if the FDA-
required labeling provides sufficient information about risks (i.e., information 
about the potential or expected risks) and effects of using the product as presented 
in the product communication.  Similarly, firms should examine any unique 
considerations associated with the use of the product as suggested by the 
communication and assess whether the FDA-required labeling furnishes the 
appropriate context. 
 
If the answer to this question is no, that indicates the product communication is 
not consistent with the FDA-required labeling. 
 
Given the potential for overlap in these three factors, FDA recognizes that there are 
questions about how a product communication that satisfies factor 1 could fail on 
factor 2 and/or 3.  As a general matter, factor 1 primarily addresses situations where 
the information about the conditions of use described in the FDA-required labeling 
and in a firms communication conflict with one another.  However, while the FDA-
required labeling provides essential information about the approved conditions of use, 
it is not intended to exhaustively address every possible scenario a firm could suggest 
in its communications  either to rule out or to endorse each possible scenario  and 
certain scenarios could negatively affect the safe and effective use of the product.  As 
a result, simply analyzing whether there is a conflict between the information in the 
 
18 This factor is not intended to restrict firms from communicating about increased risks, such as risks observed with 
use of their products in clinical practice.  For example, as described in the preceding footnote, firms 
communications can reflect changes to the labeling described in a pending CBE supplement, including supplements 
that add or strengthen contraindication, warning, precaution, or adverse reaction information in the FDA-required 
labeling, and such communications would be considered consistent with the FDA-required labeling.  It is also not 
intended to restrict communications that describe minor differences in the rate of occurrence of common, non-
serious adverse reactions (e.g., if a firms communication describes the rate of occurrence of headache observed in 
clinical practice, and this rate is slightly higher than the rate of occurrence of headache reflected in the FDA-
required labeling from the clinical trials experience, this communication would not be considered to fail this factor).  
However, if a firms communication suggests use of its product in a way that would reasonably be expected to result 
in a clinically significant increase in the rate of occurrence or severity of an adverse event compared to what is 
described in the FDA-required labeling or in a way that would reasonably be expected to introduce a new risk that is 
not described in the FDA-required labeling, that would indicate the product communication is not consistent with 
the FDA-required labeling.   
 
  6  Contains Nonbinding Recommendations 
communication and the FDA-required labeling is not always sufficient to determine 
whether a communication is consistent with the FDA-required labeling.  If a firms 
communication suggests use of its product in a way that does not conflict with the 
FDA-required labeling but which nevertheless increases the potential for harm to 
health relative to the information reflected in the FDA-required labeling, the 
communication would not be consistent with the FDA-required labeling (factor 2).  
Similarly, if a firms communication suggests use of a product in a way that does not 
conflict with the information in the FDA-required labeling but the FDA-required 
labeling would not provide adequate information to enable the product to be safely or 
effectively used under the conditions represented in the communication, the 
communication would not be consistent with the FDA-required labeling (factor 3). 
 
The following examples further illustrate how factors 2 and 3 are applied: 
 
  Example 1:  Drug A and Drug B are both indicated for the treatment of 
osteoarthritis in dogs.  Drug As FDA-required labeling states that when 
discontinuing treatment with Drug A there should be a washout period before 
switching to another drug because of an increased risk of adverse reactions from 
drug interactions if dogs are switched without a washout period between the 
drugs.  Drug Bs FDA-required labeling does not address switching from Drug A 
to Drug B.  A firms product communication for Drug B suggests that dogs can be 
immediately switched from Drug A to Drug B.  .   
 
The communication may not fail on factor 1 because there is no information in the 
FDA-required labeling for Drug B that explicitly addresses use of Drug B in dogs 
being switched from Drug A.  However, this communication would fail on factor 
2 because the information in the communication increases the potential for harm 
to health relative to the information in the FDA-required labeling for Drug B, 
which does not describe the additional risks associated with use of Drug B when 
dogs are abruptly switched to the drug from Drug A.     
 
This communication would also fail on factor 3 because the FDA-required 
labeling for Drug B would not provide adequate directions for use of Drug B 
under the conditions represented in the communication (e.g., on relevant hazards 
associated with abrupt switching from Drug A to Drug B).   
 
  Example 2:  The dosage and administration section of the FDA-approved labeling 
for a drug indicates that dose modifications may be needed based on individual 
safety and tolerability, but does not provide specific dose modification 
instructions.  A firms product communication for the drug indicates that patients 
who have tolerability issues should be dosed on a specific modified schedule set 
forth in the communication; however, this schedule would result in patients 
receiving a sub-therapeutic dose of the drug.   
 
Although the communication may not fail on factor 1 in that it does not conflict 
with the general dose modification statement in the dosage and administration 
  7  Contains Nonbinding Recommendations 
section of the FDA-approved labeling, the FDA-required labeling would not 
provide adequate information to enable the product to be used effectively under 
the dosing conditions represented in the communication, which would result in 
patients receiving a sub-therapeutic dose.  For this reason, this communication 
would fail on factor 3.  
 
Q.3.  Does FDA intend to rely on a firms product communications that are consistent 
with the FDA-required labeling to establish a new intended use? 
 
A.3.  No.  If a firms product communication is consistent with the FDA-required labeling, 
FDA does not intend to rely on that communication to establish a new intended use, 
different from the use(s) for which the product is legally marketed.  In addition, FDA 
does not intend to consider a product communication that is consistent with the FDA-
required labeling as evidence of a firms failure to comply with the FD&C Acts 
requirement that a medical products labeling bear adequate directions for use (see 
section 502(f) of the FD&C Act) based solely on the fact that the communication 
presents data and information that are not reflected in the products FDA-required 
labeling.  This is not to suggest that these communications must be excluded from 
consideration altogether.  For example, if there is other evidence of a new intended 
use for a product, product communications that are consistent with the FDA-required 
labeling may be part of the overall material that is evaluated in assessing the firms 
conduct. 
 
Even if a firms product communication is consistent with the FDA-required labeling, 
the firm also must ensure that the communication satisfies other applicable 
requirements.  In this respect, please note that the determination of whether or not a 
communication is consistent with the FDA-required labeling is separate from the 
determination of which specific labeling or advertising provisions of the FDA 
authorities, if any, apply to that communication (see Q.6/A.6 and Q.7/A.7).  
 
Q.4.  What are examples of the kinds of information that could be consistent with the 
FDA-required labeling for a product? 
 
A.4.  The following are examples of some general types of information that could be 
consistent with the FDA-required labeling.  These examples are provided for 
illustrative purposes only and are not intended to be comprehensive or restrictive.  
Furthermore, not all representations or suggestions about a product that relate to the 
general categories described in this answer will be consistent with the FDA-required 
labeling for the specific product.  That determination is fact-specific and is made by 
evaluating the particular representations or suggestions being made in a product 
communication, using the factors outlined in Q.2/A.2.   
 
  Information based on a comparison of the safety or efficacy of a medical product 
for its approved indication to another medical product approved for the same 
indication (e.g., a firms product communication provides information from a 
head-to-head study or studies indicating that its drug approved to treat high blood 
  8  Contains Nonbinding Recommendations 
pressure in adults has superior efficacy to another drug that is also approved to 
treat high blood pressure in adults)  
  Information that provides additional context about the adverse reactions 
associated with the approved uses of the product reflected in the products FDA-
required labeling (e.g., the FDA-required labeling for a product identifies nausea 
as a potential adverse reaction and further indicates the product can be taken with 
or without food.  A firms product communication provides information about 
how taking a product with food might reduce nausea)19 
  Information about the onset of action of the product for its approved indication 
and dosing/use regimen (e.g., the FDA-required labeling for a product approved 
to treat major depressive disorder does not contain information about onset of 
action before the point in time designated as the studys endpoint, and a firms 
product communication provides information indicating that the product shows an 
effect relative to the control at 2 weeks) 
  Information about the long-term safety and/or efficacy of products that are 
approved for chronic use (e.g., a firm provides postmarketing information for its 
product, which was approved for chronic use based on 24-week study data, 
regarding persistent safety and/or efficacy over 18 months)  
  Information about the effects or use of a product in specific patient subgroups that 
are included in its approved patient population (e.g., a firms product 
communication provides information on the number of female patients that were 
studied in its pivotal clinical trials and the treatment effects in that patient group, 
or, in the case of a diagnostic product, the diagnostic performance in that patient 
group) 
  Information concerning the effects of a product on the patient for its FDA-
approved indication in its approved patient population (e.g., (1) a firms product 
communication provides information concerning patient compliance/adherence; 
(2) a firms product communication for its prosthetic hip, which is approved to 
treat mobility-limiting joint disease caused by osteoarthritis, provides information 
regarding the effects of the device on relieving patients symptoms associated 
with the disease (e.g., decreased hip pain) at an interim point in time before a 
primary endpoint of improvement in function; (3) a firms product 
 
19 In June 2014, FDA issued a draft guidance entitled Distributing Scientific and Medical Publications on Risk 
Information for Approved Prescription Drugs and Biological Products  Recommended Practices (Risk 
Information Draft Guidance). (When final, this guidance will represent FDAs current thinking on this topic.)  That 
draft guidance relates to information that becomes available after a drug is marketed that rebuts or mitigates 
information about a risk already identified in the approved labeling or otherwise refines risk information in the 
approved labeling in a way that does not indicate greater seriousness of the risk (page 3 (footnote omitted)).  To the 
extent there is overlap between the Risk Information Draft Guidance and this guidance, FDA recommends that firms 
consider the recommendations in both guidances.   
 
  9  Contains Nonbinding Recommendations 
communication provides information about patients perceptions of a known 
adverse reaction associated with use of the product for its approved indication; (4) 
a firms product communication for its vascular interventional device provides 
information regarding procedure-related pain for patients who are treated with the 
device for its approved use) 
  Information concerning product convenience (e.g., (1) a firms product 
communication for its drug, which is indicated for the treatment and prevention of 
ectoparasites in dogs, provides information about the convenient dosing schedule 
of the product for pet owners based on its long duration of effect; (2) a firms 
product communication for its drug, which is administered by subcutaneous 
injection, conveys that its administration time is more convenient than another 
product with the same active ingredient indicated for the same condition which is 
administered through an intravenous infusion, by providing information that its 
subcutaneous injection requires an average of 3 hours in the clinic versus an 
average of 10 hours in the clinic for infusion of the other product) 
  Information that provides additional context about the mechanism of action 
described in the FDA-required labeling (e.g., the FDA-required labeling for a 
drug product indicates it exerts its effects by binding to a certain receptor, and a 
firms product communication provides additional information about the 
products selectivity for that receptor)  
  Information about the tolerability of a product when used concomitantly with 
another product for a co-morbid condition (e.g., a firms product communication 
for its drug, which is approved for the treatment of hypertension, provides 
postmarket information indicating that patients within its FDA-approved 
population who are also receiving treatment with another product for their type 2 
diabetes mellitus reported tolerability of the hypertension drug that was 
comparable to that of patients taking the drug during clinical trials, who were not 
taking the concomitant medication)  
Q.5.   What are examples of the kinds of information that are not considered consistent 
with the FDA-required labeling for a product? 
 
A.5.  Some examples of general types of information that are not considered consistent 
with the FDA-required labeling include the following.  As with the examples 
provided in Q.4/A.4, these examples are provided for illustrative purposes only and 
are not intended to be comprehensive.   
 
  Information about the use of a product to treat or diagnose a different disease or 
condition than the product is approved to treat or diagnose (e.g., a product is 
approved to treat cardiovascular disease, and a firms product communication 
provides information about using the product to treat diabetes) 
  Information about the use of a product to treat or diagnose patients who are not 
included in the products approved patient population (e.g., (1) a device is 
indicated for the quantitation of hepatitis B virus (HBV) DNA in human blood 
  10  Contains Nonbinding Recommendations 
samples of previously diagnosed HBV-infected individuals as an aid in the 
management of patients with chronic HBV infection undergoing anti-viral 
therapy, and a firms product communication provides information about using 
the device to make an initial diagnosis of HBV infection in previously 
undiagnosed patients; (2) an animal drug is approved only for use in feedlot cattle, 
and a firms product communication provides information about using the product 
in veal or dairy cattle) 
  Information about the use of a product to treat a different stage, severity, or 
manifestation of a disease than the product is approved to treat (e.g., a product is 
approved only to treat severe asthma, and a firms product communication 
provides information about using the product to treat patients with mild asthma) 
  Information about the use of a product as monotherapy when it is only approved 
for use in conjunction with one or more other products or therapeutic modalities 
(e.g., the FDA-required labeling for a product indicates it is for use as an adjunct 
to surgery and radiation, and a firms product communication provides 
information about using the product to treat patients who are not undergoing 
surgery and radiation)  
 
  Information about using a product through a different route of administration or in 
a different tissue type than the product is approved for (e.g., a product is approved 
only for intramuscular injection, and a firms product communication indicates 
the product can be injected intravenously) 
  Information about the use of a different strength, dosage, or use regimen than the 
approved strength, dosage, or use regimen (e.g., the FDA-required labeling for a 
drug indicates it should be taken twice a day 12 hours apart, and a firms product 
communication represents that the product can instead be taken once a day, with 
both doses being taken together in the morning) 
  Information about the use of a product in a different dosage form than what is set 
forth in the FDA-required labeling (e.g., the products approved dosage form is a 
capsule, and a firms product communication provides information about use of 
the product as an oral solution) 
 
Q.6.  What evidentiary support should a firm have for its CFL promotional 
communications? 
 
A.6.  Under the FD&C Act and FDAs implementing regulations, labeling for drugs and 
devices and advertising for prescription drugs and restricted devices must be truthful 
and non-misleading, which includes revealing facts that are material about the 
product being promoted, including information about the risks of the product.20  
When these communications lack appropriate evidentiary support, they are likely to 
 
20 See, for example, sections 201(n), 502(a), 502(n), 502(q), and 502(r) of the FD&C Act; 21 CFR 202.1(e)(5). 
  11  Contains Nonbinding Recommendations 
be false or misleading and can cause patient harm.  To be truthful and non-
misleading, representations or suggestions made by firms about their products need to 
be grounded in fact and science and presented with appropriate context.  Any data, 
studies, or analyses relied on should be scientifically appropriate and statistically 
sound to support the representations or suggestions made in a CFL promotional 
communication.   
 
The safety and effectiveness of the drug or device under the conditions of use in the 
FDA-required labeling have already been established by appropriate evidence during 
the premarket review process (and/or through the device classification process).  
Therefore, FDA would not consider representations or suggestions in a CFL 
promotional communication to be false or misleading based only on the lack of 
evidence sufficient to satisfy the applicable approval/clearance standard.  For 
example, evidence other than that which meets the new drug approval standard of 
substantial evidence of effectiveness could be used to support certain 
representations or suggestions about a prescription drug in a CFL promotional 
communication.21  Nevertheless, the communication could be false or misleading for 
other reasons.  Accordingly, the representations or suggestions should be supported 
and presented as described in this guidance.     
 
The amount and type of evidence needed to support a particular CFL promotional 
communication depends in part on the topic addressed by the communication.  For 
example, different evidence would be needed to support a long-term efficacy 
presentation than would be needed to support a presentation about a products 
mechanism of action.  The amount and type of evidence needed also depends on the 
particular representations or suggestions that are made about any given topic in the 
communication.  We are aware that firms are interested in including information from 
a variety of types of studies and analyses in their product communications, including 
additional information from the studies that supported approval or clearance of their 
product and from postmarket studies and analyses of their product.  As a general 
matter, FDA believes that a variety of types of studies and analyses can provide 
useful additional information about a medical product for its approved/cleared 
conditions of use.  However, some of these studies or analyses do not, in and of 
themselves, allow for reliable conclusions to be drawn about the effects of the 
product.  To be considered truthful and non-misleading, firms product 
communications should not overstate the findings of or the conclusions that can be 
drawn from such studies or analyses, or fail to disclose their material limitations.  
 
For example, certain analyses of pivotal trial data may provide information that 
elaborates on the data reflected in the products FDA-required labeling and could add 
to understanding of a product (e.g., information from separate analyses of the 
individual components of a composite endpoint that was successfully used as the 
 
21 In such circumstances, FDA does not intend to interpret its regulations, see, for example, 21 CFR 202.1(e)(6)(i), 
to the contrary. 
  12  Contains Nonbinding Recommendations 
primary endpoint and that are derived from appropriate statistical tests22 and pre-
specified in the statistical analysis plan).  However, if the pivotal trial was, for 
example, not adequately powered to determine treatment effect on the individual 
components of the composite endpoint and/or type 1 error (false positive rate) was 
not controlled in these analyses, these analyses would generally not support 
conclusions about a treatment effect of the product on the individual components of 
the composite endpoint.  In such a case, representing or suggesting that the data 
support such efficacy conclusions, either directly (e.g., by claiming the product has 
demonstrated efficacy on the individual components) or indirectly (e.g., by presenting 
p-values, which would imply a statistically rigorous conclusion where one does not 
exist), would be false or misleading.  
 
If the firm wishes to present this information in a CFL promotional communication, it 
must do so in a truthful and non-misleading way.23  For example, the firm could 
present the results from these analyses of the individual components of the composite 
endpoint descriptively without p-values and without claiming that the results on the 
individual components are demonstrated additional effects of the drug.  The firm 
should also include contextual information to describe the material limitations of the 
data (see Q.8/A.8)  e.g., for this particular presentation, the firm could explain that 
because these analyses were not prespecified and appropriate multiplicity adjustments 
were not applied, the results on the individual components need cautious 
interpretation and could represent chance findings.   
 
Thus, in addition to being scientifically appropriate and statistically sound, the 
evidence should be accurately characterized in the CFL promotional communication, 
including limitations of the strength of the evidence and the conclusions that can be 
drawn from it (as discussed in Q.8/A.8).  However, firms should note that if a CFL 
promotional communication relies on a study that is inadequate to support the 
representations or suggestions it presents, disclosure of the material limitations of that 
study does not correct the misleading message conveyed by the communication.  For 
example, in the scenario described in the previous paragraphs, if the firms 
communication represented or suggested that the results on the individual 
components are demonstrated additional effects of the drug, disclosing the limitations 
of the underlying evidence would not correct the misleading message conveyed by 
the communication.  Rather, as previously mentioned, the information should be 
presented in a way that does not overstate the conclusions that can be drawn from the 
supporting evidence.  And if a firms communication is based on speculation or belief 
without scientific support or is based on a poorly designed or conducted study or 
analysis, that communication would not be consistent with the recommendations in 
 
22 See, for example, FDAs guidance E9 Statistical Principles for Clinical Trials (September 1998); FDAs guidance 
Design Considerations for Pivotal Clinical Investigations for Medical Devices (November 2013); and FDAs 
guidance Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests (March 2007).   
23 See sections 502(a), 502(n), 502(q), and 502(r) of the FD&C Act; 21 CFR 1.21 (a) and 202.1(e)(5). 
  13  Contains Nonbinding Recommendations 
this guidance, regardless of whether the communication discloses the lack of 
appropriate support for the information being presented.  
 
Q.7.  What other considerations apply to CFL promotional communications that are 
consistent with the FDA-required labeling?  
 
A.7.  In addition to the considerations addressed in Q.6/A.6, firms should ensure their 
FDA-regulated promotional materials otherwise satisfy the applicable requirements of 
the FD&C Act and FDAs implementing regulations.    
 
Nothing in this guidance is intended to change a firms existing obligations under the 
FD&C Act, the Public Health Service Act (PHS Act), or FDAs implementing 
regulations to update its FDA-required labeling to ensure that the labeling is not false 
or misleading or for other reasons.24   
 
Q.8.  What does FDA recommend that firms consider when developing CFL promotional 
communications that are consistent with the FDA-required labeling to help ensure 
that the presentation of this information does not render the communication false 
or misleading? 
 
A.8.  The way a firm presents information that is consistent with the FDA-required labeling 
(including the express and implied claims made and the overall impression created by 
the communication as a whole) affects how the information is understood.  The 
following are some high-level recommendations for firms to consider when 
developing their presentations of information in CFL promotional communications to 
help ensure the presentations do not mislead the applicable audience(s): 
 
  Any study results or other data and information that are relied upon to support a 
firms CFL promotional communication should be accurately represented in the 
communications.  Moreover, aspects of study design and methodology that are 
material for audiences to accurately interpret the information presented (e.g. type 
of study, study objectives, product dosage/use regimens, controls used, patient 
population studied) from any studies relied on should be clearly and 
prominently25 disclosed in firms CFL promotional communications, and material 
 
24 See, for example, 21 CFR 201.56(a)(2) ([approved] labeling must be updated when new information becomes 
available that causes the labeling to become inaccurate, false, or misleading); 21 CFR 314.70 and 601.12 
(concerning supplements and other changes to an approved application, including labeling); 21 CFR 514.8(c) 
(concerning supplements and other changes to an approved application for a new animal drug, including labeling); 
21 CFR 814.39 (concerning supplements to an approved premarket approval application (PMA), including labeling); 
and 21 CFR 814.108 (concerning supplements to an approved HDE application, including labeling).   
25 In evaluating whether information is presented clearly and prominently, FDA considers the conspicuousness of 
the information as compared to other statements and presentations in the communication (including factors such as 
location, font size, contrast, and white space) and also considers whether it is presented in a way that is likely to be 
read and understood by those receiving the communication.   
 
  14  Contains Nonbinding Recommendations 
limitations related to the study design, methodology, and results should also be 
disclosed in a clear and prominent manner.  
  The CFL promotional communication should accurately characterize and 
contextualize the relevant information about the product, including by disclosing 
unfavorable or inconsistent findings.  For example, if a firm presents efficacy 
results from a postmarketing study of its product that evaluated the effect of the 
product on two different endpoints, such as overall survival and progression-free 
survival, and the product failed to demonstrate an effect on one of these two 
endpoints, the firm should clearly and prominently disclose this in the CFL 
promotional communication, rather than selectively presenting only the positive 
efficacy results.  
  If the FDA-required labeling contains data or information related to what is being 
represented/suggested in the CFL promotional communication, the 
communication should also include the data or information from the FDA-
required labeling to provide the audience with appropriate context, and this 
information should be presented in a clear and prominent way.  For example, if a 
communication provides postmarketing information about the types and rates of 
occurrence of adverse events that have been observed in practice, the 
communication should also include information from the FDA-required labeling 
about the types and rates of occurrence of adverse reactions observed in clinical 
trials to provide context.   
These considerations are not intended to be a comprehensive description of 
everything a firm should factor into its analysis of whether its presentations are 
truthful and non-misleading.  FDA recommends that, before disseminating a CFL 
promotional communication, firms should have qualified medical/scientific, legal, 
and regulatory personnel carefully review the communication to ensure it is not false 
or misleading.  
 
Q.9.  What are some examples of promotional communications that are consistent with 
the FDA-required labeling and with the recommendations in this guidance? 
 
A.9.  The following are two examples of promotional communications FDA would 
consider to be consistent with the FDA-required labeling and the recommendations in 
Q.6/A.6 and Q.8/A.8.  
 
Example 1:  Product B is an Immune Globulin Intravenous (Human), 10% liquid 
indicated for the treatment of primary humoral immunodeficiency (PI) and chronic 
immune thrombocytopenic purpura (IPT).  Product Bs firm develops promotional 
materials which communicate that clearance of Product B is comparable in males and 
females taking it to treat PI and IPT.  These materials cite to the pharmacokinetic 
information obtained from the pivotal study of the product.   
 
Is this consistent with the FDA-required labeling?  Yes.  This claim about the product 
is within the scope of the uses approved by FDA, because the FDA-required labeling 
  15  Contains Nonbinding Recommendations 
reflects that the product is indicated for use in both males and females to treat PI and 
IPT, and does not contain any limitations or directions or other special considerations 
related to the gender of patients using the product.  The representation about similar 
clearance of the product in males and females is not expected to increase the potential 
for harm to patients, and the directions in the FDA-required labeling enable the 
product to be safely and effectively used to treat PI and IPT regardless of gender.  
This would be an example of a promotional communication that FDA would consider 
to be consistent with the FDA-required labeling.   
 
Is this truthful and non-misleading?  Yes, assuming the clearance information from 
the pivotal study is accurately reported in the firms CFL promotional communication 
and the material aspects of the underlying study design and methodology are 
disclosed, including any material limitations of the information.  As indicated in 
Q.7/A.7, the firm should also ensure the rest of the information in the CFL 
promotional communication is truthful and non-misleading and satisfies any other 
applicable requirements.   
 
Example 2:  An implantable device is approved for use as an adjunctive therapy for 
reducing symptoms of a chronic disease when symptoms are not adequately 
controlled by medication.  The device is clinician/patient-controlled based on the 
disease state and symptoms.  The directions for use do not prescribe a specific use 
schedule.  In the clinical study that supported the devices premarket approval 
application (PMA), approximately half of the patients using the device reported 
severe headaches, but many patients tolerate this risk because of the benefits of 
amelioration of symptoms associated with their chronic illness.   
 
The firm enrolled patients with the implanted device in a postmarketing registry, 
which was designed to better identify and quantify rare adverse events and evaluate 
the longer-term effectiveness of the therapy.  In addition to clinical visits for follow-
up, patients used a diary to record device use, symptoms, and adverse events.  Data 
from the registry suggest that patients who use the device more frequently and for 
shorter periods of time (such use is consistent with the approved labeling) experience 
comparable benefits in ameliorating the symptoms associated with their chronic 
illness as were observed in the clinical study supporting the PMA, but that these 
patients have a reduced incidence of severe headaches associated with use of the 
device compared to that reported in the PMA-approved labeling.   
 
The device firm develops promotional materials to communicate this information 
about the reduced incidence of severe headaches; these materials also outline specific 
information regarding the registry, including the number of patients enrolled in the 
registry, patient population, outcome measures, and a summary of the device use, as 
well as symptoms and adverse events reported in the patient diaries.  The proposed 
promotional materials clearly disclose that the trends related to the diary information 
about the reduced incidence of severe headaches are descriptive, not statistically 
powered, and not pre-specified, and that this information should be cautiously 
  16  Contains Nonbinding Recommendations 
interpreted and may result from chance.  They also disclose the data from the 
premarket clinical study along with the registry data to provide context.   
 
Is this consistent with the FDA-required labeling?  Yes.  These representations about 
the use of the product are within the scope of the uses approved by FDA, because the 
product is being used for its approved indication in its approved patient population 
and in a manner that comports with the directions for use in the FDA-required 
labeling.  These representations are not expected to increase the potential for harm to 
patients relative to the information reflected in the FDA-required labeling.  The 
directions for use in the FDA-required labeling enable the product to be safely and 
effectively used under the conditions represented in the communication.  While the 
promotional materials provide supplementary information about use of the device in a 
specific manner, the information provided is consistent with the directions for use in 
the labeling, which do not prescribe a specific use schedule, and the information does 
not otherwise alter or compromise the directions for use in the FDA-required 
labeling.  A firms communication of this information would be considered consistent 
with the FDA-required labeling. 
 
Is this truthful and non-misleading?  If the data and information are accurately 
reported in the firms promotional materials and the material aspects of the 
underlying study design and methodology are disclosed in the materials, including 
material limitations of the information, FDA would consider this to be truthful and 
non-misleading.  Provided the rest of the information in the promotional materials is 
truthful and non-misleading, this is an example of a CFL promotional communication 
that FDA would also consider to be consistent with the recommendations in Q.6/A.6 
and Q.8/A.8. 
 
Q.10.  What are examples of promotional communications FDA would consider to be 
inconsistent with the FDA-required labeling or inconsistent with the 
recommendations in this guidance? 
 
A.10.  Here are two examples.  The first illustrates a promotional communication that FDA 
would consider to be inconsistent with the FDA-required labeling, and the second 
illustrates a CFL promotional communication that FDA would consider to be 
inconsistent with the recommendations in Q.6/A.6 and Q.8/A.8. 
 
Example 1:  A drug is indicated for the treatment of bovine respiratory disease (BRD) 
associated with certain susceptible bacteria in beef and non-lactating dairy cattle.  The 
firm develops promotional materials to communicate information about the use of the 
drug to prevent BRD if used 5 days before shipment of cattle.   
 
Is this consistent with the FDA-required labeling?  No.  These representations about 
the use of the product are not within the scope of the uses approved by FDA.  
Treatment of BRD and prevention of BRD are distinct indications, and this drug is 
not approved for prevention of BRD.  The FDA-required labeling for treatment of 
BRD does not provide directions for using the product for disease prevention.  
  17  Contains Nonbinding Recommendations 
Moreover, the administration of the drug to cattle 5 days before shipment to prevent 
BRD would reasonably be expected to increase the risk to health (including to the 
health of cattle and of humans) from resistant bacteria originating from treated cattle.  
FDA considers appropriate risk factors, including considerations of animal and public 
health, in determining whether an animal drug product is safe and effective under 
particular conditions of use.   
 
Example 2:  Drug A is approved for the long-term, maintenance treatment of asthma 
patients 12 years of age and older.  The safety and efficacy of Drug A for this 
indication was evaluated versus placebo treatment in a randomized, double-blind 
study.  The study also included an active comparator (Drug B), approved for the same 
indication and with a comparable risk profile, which was similarly evaluated versus 
placebo.  The study was not designed to test the non-inferiority or superiority of Drug 
A directly against Drug B (i.e., the Drug B arm was included for assay sensitivity).  
Drug A and Drug B demonstrated statistically significant improvements versus 
placebo in the co-primary efficacy endpoints, but Drug As results showed a 
numerically greater improvement versus placebo than those for Drug B.  Based on 
this study, Drug As firm develops promotional materials to communicate that Drug 
A is clinically superior to Drug B for the long-term, maintenance treatment of asthma 
patients 12 years of age and older. 
 
Is this consistent with the FDA-required labeling?  Yes.  The information the firm 
proposes to present is within the scope of the uses approved by FDA for Drug A.  The 
promotional material relates to the indicated use of Drug A in the approved patient 
population at the same dosing strength and frequency recommended in the FDA-
required labeling.  The information is not expected to increase the potential for harm 
to the health of patients relative to the information reflected in the FDA-required 
labeling  both Drug A and Drug B are approved for the same indication and patient 
population and have similar risk profiles.  Furthermore, the directions in the FDA-
required labeling enable Drug A to be safely and effectively used under the 
conditions presented in the promotional material.  This promotional communication 
could be considered consistent with the FDA-required labeling. 
 
Is this truthful and non-misleading?  No.  The promotional material is misleading 
because it makes a claim of superior effectiveness for Drug A versus Drug B based 
on a study that was not designed to establish superiority of Drug A to Drug B.  Thus, 
the CFL promotional communication would not be consistent with the 
recommendations in Q.6/A.6 and Q.8/A.8.   
 
If the firm wishes to present data and information from this study, it should do so in a 
truthful and non-misleading way.  For example, the firm could describe the study 
design and objectives, including the material limitations of both, and include 
prominent contextual information that the study was not designed to provide 
comparative efficacy data and should not be interpreted as providing evidence of 
either superiority or non-inferiority of Drug A to Drug B.  The CFL promotional 
communication should not contain representations or suggestions that are not 
  18  Contains Nonbinding Recommendations 
supported by appropriate evidence, such as any representation or suggestion of Drug 
As superior effectiveness over Drug B. 
 
Q.11.  What are the Agencys policies for communication of information that is not 
consistent with the FDA-required labeling (i.e., information about unapproved uses 
of approved/cleared medical products)? 
 
A.11.  A determination that a product communication is not consistent with that products 
FDA-required labeling does not necessarily mean the communication is one that FDA 
would rely on as relevant to establishing a violation of FDA-administered legal 
authorities.  There are other potentially relevant regulations, guidance documents, and 
policies that describe the Agencys views and enforcement priorities that could apply 
in this situation.  For example, FDA has issued a draft guidance describing how firms 
can respond to unsolicited requests for unapproved use information related to their 
FDA-approved prescription drugs and FDA-approved or cleared devices.26  In 
addition, FDA has provided separate guidances describing recommended practices for 
firms for the dissemination of scientific and medical publications discussing 
unapproved uses of approved drugs or approved or cleared devices.27,28 
 
 
IV.  PAPERWORK REDUCTION ACT OF 1995 
 
This guidance contains information collection provisions that are subject to review by the Office 
of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3520).  Specifically, in Q.8/A.8 the guidance contains recommendations regarding 
information that firms should include in communications that contain information not found in 
the FDA-required labeling for their medical products but that are consistent with the FDA-
required labeling.   
 
FDA estimates that it will take firms approximately 4 hours per unique presentation to prepare 
and incorporate the information that this guidance recommends should be included in their CFL 
promotional communications.  Send comments regarding this burden estimate or suggestions for 
reducing this burden to: 
 
 
26 See FDAs draft guidance Responding to Unsolicited Requests for Off-Label Information About Prescription 
Drugs and Medical Devices Practices (December 2011).  When final, this guidance will represent FDAs current 
thinking on this topic.   
27 See FDAs guidance Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or 
Scientific Reference Publication on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical 
Devices (January 2009).  
28 See FDAs revised draft guidance Distributing Scientific and Medical Publications on Unapproved New Uses  
Recommended Practices (February 2014).  When final, this guidance will represent FDAs current thinking on this 
topic.  
  19  Contains Nonbinding Recommendations 
FDA PRA Staff, Office of Operations; Food and Drug Administration;  
Three White Flint North; 11601 Landsdown Street, 10A-12M; North Bethesda, MD 
20852 
 
An Agency may not conduct or sponsor, and a person is not required to respond to, a collection 
of information unless it displays a currently valid OMB control number.  The OMB control 
number for this information collection is 0910-0856 (expires 08/31/2024 (Note:  OMB control 
number and expiration date added 09/28/2021)). 
 
  20