Considerations for the Use 
of Real-World Data and 
Real-World Evidence to 
Support Regulatory 
Decision-Making for Drug 
and Biological Products 
 
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) 
Oncology Center of Excellence (OCE) 
 
August 2023 
 Real-World Data/Real-World Evidence (RWD/RWE) 
54767258fnl   
Considerations for the Use  
of Real-World Data and Real-
World Evidence to Support 
Regulatory Decision-Making 
for Drug and Biological 
Products 
Guidance for Industry 
 
Additional copies are available from: 
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Center for Drug Evaluation and Research 
Food and Drug Administration 
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Silver Spring, MD 20993-0002  
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Email: druginfo@fda.hhs.gov  
 https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs 
and/or 
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 Food and Drug Administration 
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Email: ocod@fda.hhs.gov 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-
guidances     
 
 
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) 
Oncology Center of Excellence (OCE) 
 
August 2023 
 Real-World Data/Real-World Evidence (RWD/RWE) 
  Contains Nonbinding Recommendations 
TABLE OF CONTENTS 
 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  REGULATORY CONSIDERATIONS ADDRESSED ................................................. 3 
A.  Applicability of 21 CFR Part 312 ................................................................................................. 3 
B.  Regulatory Considerations for Non-Interventional Studies ...................................................... 4 
1. Overview .......................................................................................................................................... 4 
2. Transparency Regarding Data Collection and Analysis ................................................................. 5 
3. Access to RWD ................................................................................................................................. 6 
4. Study Monitoring ............................................................................................................................. 7 
5. Safety Reporting ............................................................................................................................... 8 
6. Other Sponsor Responsibilities ........................................................................................................ 8 
  Contains Nonbinding Recommendations 
Considerations for the Use of Real-World Data and Real-World 
Evidence to Support Regulatory Decision-Making for Drug and 
Biological Products 
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  
 
The 21st Century Cures Act (Cures Act),2 signed into law on December 13, 2016, is intended to 
accelerate medical product development and bring innovations faster and more efficiently to the 
patients who need them.  Among other provisions, the Cures Act added section 505F to the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355g).  Pursuant to this section, 
FDA created a framework for a Real-World Evidence (RWE) Program3 to evaluate the potential 
use of RWE in regulatory decision-making for drugs.4 
 
FDA is issuing this guidance as part of its RWE Program to satisfy, in part, the mandate under 
section 505F of the FD&C Act to issue guidance about the use of RWE to help support approval 
of a new indication for a drug already approved under section 505(c) of the FD&C Act (21 
U.S.C. 355(c)) or to help support postapproval study requirements.5   
 
 
1 This guidance has been prepared by the Center for Drug Evaluation and Research in cooperation with the Center 
for Biologics Evaluation and Research and the Oncology Center of Excellence at the Food and Drug Administration.  
 
2 Public Law 114-255.  
 
3 See the Framework for FDAs Real-World Evidence Program, available at 
https://www.fda.gov/media/120060/download.  The framework and RWE Program also cover biological products 
licensed under the Public Health Service Act.  
 
4 For the purposes of this guidance, all references to drug or drugs include both human drugs and biological 
products.   
 
5 See section 505F(e) of the FD&C Act. 
  1  Contains Nonbinding Recommendations 
For the purposes of this guidance, FDA defines real-world data (RWD) and RWE as follows: 
 
  RWD are data relating to patient health status and/or the delivery of health care routinely 
collected from a variety of sources. 
 
  RWE is the clinical evidence about the usage and potential benefits or risks of a medical 
product derived from analysis of RWD. 
 
This guidance discusses the applicability of FDAs investigational new drug application (IND) 
regulations under part 312 (21 CFR part 312) to various clinical study6 designs that utilize RWD.  
The guidance also clarifies the Agencys expectations concerning clinical studies using RWD 
submitted to FDA in support of a regulatory decision regarding the effectiveness and safety of a 
drug (e.g., as part of a new drug application (NDA) or biologics license application (BLA)) when 
such studies are not subject to part 312.  This guidance focuses primarily on clinical study 
designs that are non-interventional.  
 
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 
 
For the purposes of this guidance, the term interventional study (also referred to as a clinical 
trial) is a study in which participants, either healthy volunteers or volunteers with the condition 
or disease being studied, are assigned to one or more interventions, according to a study protocol, 
to evaluate the effects of those interventions on subsequent health-related outcomes.  One 
example of an interventional study is a traditional randomized controlled trial in which some 
participants are randomly assigned to receive a drug of interest (test article), whereas others 
receive an active comparator drug or placebo.  Other examples of interventional study designs 
include randomized clinical trials with pragmatic elements (e.g., broad eligibility criteria, 
recruitment of participants in routine care settings) and single-arm trials. 
 
For the purposes of this guidance, a non-interventional study (also referred to as an observational 
study) is a type of study in which patients received the marketed drug of interest during routine 
medical practice and are not assigned to an intervention according to a protocol.  Examples of 
non-interventional study designs include, but are not limited to, (1) observational cohort studies, 
in which patients are identified as belonging to a study group according to the drug or drugs 
 
6 For the purposes of this guidance, the term clinical study means research that evaluates human health outcomes 
associated with taking a drug of interest.  Clinical studies include interventional (clinical trial) designs and non-
interventional (observational) designs (see section II in this guidance).  The fact that this guidance refers to clinical 
trials as a type of clinical study should not be read to suggest that FDA considers clinical trials to be studies under 
section 505(o) of the FD&C Act (21 U.S.C. 355(o)), which authorizes FDA under specific conditions to require 
postapproval clinical trials and studies.   
  2  Contains Nonbinding Recommendations 
received or not received during routine medical practice, and subsequent biomedical or health 
outcomes are identified and (2) case-control studies, in which patients are identified as belonging 
to a study group based on having or not having a health-related biomedical or behavioral 
outcome, and antecedent treatments received are identified. 
 
 
III.  REGULATORY CONSIDERATIONS ADDRESSED 
 
A.  Applicability of 21 CFR Part 312 
 
This section discusses the applicability of part 312 (Investigational New Drug Application) to 
studies involving the use of RWD. 
 
  FDA regulations under part 312 outline procedures and requirements governing the use 
of investigational new drugs, including the requirements for an IND submission to and 
review by FDA.  Under  312.3, a clinical investigation is defined as any experiment in 
which a drug is administered or dispensed to, or used involving, one or more human 
subjects.  For the purposes of this part, an experiment is any use of a drug except for the 
use of a marketed drug in the course of medical practice. 
 
 
  Interventional studies involving drugs generally meet the definition of a clinical 
investigation under  312.3 and are subject to FDA regulations under part 312 as 
described in  312.2.  FDA recognizes the potential utility of using RWD in 
interventional studies; for example, to identify potential participants for a randomized 
controlled trial, to ascertain endpoints or outcomes (e.g., occurrence of stroke or other 
discrete events, hospitalization, survival) in a randomized controlled trial, or to serve as a 
comparator arm in an externally controlled trial,7 including historically controlled trials.8  
 
  Non-interventional studies analyze data reflecting the use of a marketed drug 
administered in routine medical practice, according to a medical providers clinical 
judgment and based on patient characteristics, rather than assignment of a participant to a 
study arm according to a research protocol.  As such, non-interventional studies are not 
clinical investigations as defined under  312.3 and do not require an IND. 
 
 
 
7 An externally controlled trial is an interventional study, which will generally be subject to part 312 regardless of 
the source of the data for the external control.  Additional considerations for external controls are addressed in the 
draft guidance for industry Considerations for the Design and Conduct of Externally Controlled Trials for Drug and 
Biological Products (February 2023).  When final, this guidance will represent FDAs current thinking on this topic.  
We update guidances periodically.  For the most recent version of a guidance, check the FDA guidance web page at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents. 
 
8 FDA regulations under 21 CFR 314.126 outlining the characteristics of adequate and well-controlled studies 
discuss the use of historical controls as comparators in clinical studies.  Additional considerations for historical 
controls are addressed in the draft guidance for industry Rare Diseases:  Natural History Studies for Drug 
Development (March 2019) (when final, this guidance will represent FDAs current thinking on this topic) and in the 
guidance for industry E10 Choice of Control Group and Related Issues in Clinical Trials (May 2001).   
  3  Contains Nonbinding Recommendations 
B.  Regulatory Considerations for Non-Interventional Studies  
 
This section discusses regulatory considerations for non-interventional studies involving the use 
of RWD.  
 
1.  Overview 
 
  Regardless of a studys interventional or non-interventional design, the evidence 
submitted by a sponsor in a marketing application to support the safety and/or 
effectiveness of a drug must satisfy the applicable legal standards for the application to be 
approved or licensed.9  
 
  Although many non-interventional studies involve only the analysis of data reflecting the 
use of a marketed drug in routine medical practice, certain non-interventional studies 
include protocol-specified activities or procedures (e.g., questionnaires, laboratory tests, 
imaging studies) that collect additional data to help address questions of interest in these 
studies.  FDA does not consider these types of studies to be clinical investigations under 
part 312, and an IND is not required.10  Nonetheless, the protection of human subjects 
under these circumstances is critical, and sponsors must ensure that applicable 
requirements per FDA regulations under 21 CFR parts 50 (Protection of Human Subjects) 
and 56 (Institutional Review Boards) are met. 
 
  Various sources of RWD can be analyzed in non-interventional studies, including 
registries, electronic health records (EHRs), and medical claims.  The topics discussed in 
this guidance apply to any type of RWD, including data on products used in clinical 
practice under an emergency use authorization (EUA).11   
 
9 See section 505 of the FD&C Act (21 U.S.C. 355), section 351 of the Public Health Service Act (42 U.S.C. 262), 
and 21 CFR parts 314 and 601.  Similarly, non-interventional studies may be required by FDA as a postmarketing 
requirement under section 505(o)(3) of the FD&C Act (21 U.S.C. 355(o)(3)) (or other authorities) or agreed upon 
between FDA and an applicant as a postmarketing commitment.  Such studies carry specific obligations not 
addressed in this guidance.  See, e.g., the discussion of postmarketing requirements and postmarketing commitments 
in the revised draft guidance for industry Postmarketing Studies and Clinical TrialsImplementation of Section 
505(o)(3) of the Federal Food, Drug, and Cosmetic Act (October 2019).  When final, this guidance will represent 
FDAs current thinking on this topic.  
 
10 If the protocol-specified activities or procedures alter the patients treatment regimens or plans, the study becomes 
interventional and requires an IND, unless exempt, because the drug is no longer being used in the course of 
medical practice.  See 21 CFR 312.3(b). 
 
11 Under section 564 of the FD&C Act (21 U.S.C. 360bbb-3), during the effective period of a declaration of 
emergency or threat justifying EUA, FDA may authorize for use during an actual or potential emergency 
unapproved products or unapproved uses of approved products to diagnose, treat, or prevent serious or life-
threatening diseases or conditions caused by chemical, biological, radiological, or nuclear threats when certain 
criteria are met.  When products are used in clinical practice under EUA, outcomes and other variables of interest 
may be captured in relevant RWD sources, such as a patients EHR.  When fit for use, RWD reflecting the use of a 
product under EUA can be used to generate RWE about the safety and/or effectiveness of that product.  Thus, 
considerations for the inclusion, in an application or submission to FDA, of data obtained regarding the use of 
medical products under EUA are the same for the inclusion of RWD obtained regarding the use of other medical 
products in clinical practice.  
  4  Contains Nonbinding Recommendations 
 
  When appropriate, sponsors should consult with experts who consider data privacy issues 
to provide input on the protocol as part of the study design process for a non-
interventional study, as these experts may help identify and address data privacy and 
security concerns raised when accessing health care data. 
 
2.  Transparency Regarding Data Collection and Analysis 
 
  Sponsors planning to use a non-interventional study to support a marketing application 
should engage with FDA early in the drug development process using an appropriate 
regulatory pathway (e.g., requesting a Type C meeting through an existing IND for the 
product).12  Early engagement will help address the appropriateness of using a non-
interventional study design and the proposed data sources to address the research 
question of interest.  Additionally, early engagement will allow for timely identification 
of challenges in the design and planning of a non-interventional study and for discussion 
of how such challenges might be addressed.  When submitting a meeting request, 
sponsors should include adequate informationas outlined in FDA guidance for formal 
meetingsfor FDA to both assess the potential utility of a meeting and to identify 
relevant FDA subject matter experts who should address the proposed agenda items.   
 
  Sponsors should provide draft versions of their proposed protocol and statistical analysis 
plan (SAP) for Agency review and comment, prior to finalizing these documents and 
before conducting the study analyses. 
 
  To adequately assess the results of a non-interventional study supporting a marketing 
application, FDA must be confident (based on corresponding documentation) that 
particular data sources or databases were not selected, or that specific analyses were not 
conducted, to favor a certain conclusion.  The protocol and SAP should be finalized and 
shared with FDA prior to conducting the prespecified analyses described in the protocol 
and SAP.  In addition, any revisions to the protocol should be date-stamped, and the 
rationale for each change should be provided. 
 
  FDA recognizes that evaluation of relevant data sources or databases is an important step 
in the design of a study and in evaluating a studys feasibility.  Such evaluations of data 
sources or databases for feasibility purposes serve as a way for the sponsor and FDA to 
(1) assess if the data source or database is fit for use to address the research question 
being posed and (2) estimate the statistical precision of a potential study without 
evaluating outcomes for treatment arms.  
 
  Sponsors should describe in the study protocol, or as an appendix to the protocol, the data 
sources evaluated when designing the study, including results from feasibility evaluations 
or exploratory analyses of those data sources.  Sponsors should provide a justification for 
selecting or excluding relevant data sources from the study.  Sponsors should also 
 
12 See the draft guidance for industry Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA 
Products (December 2017).  When final, this guidance will represent FDAs current thinking on this topic. 
  5  Contains Nonbinding Recommendations 
describe how the choice of the final data sources, study design elements, and analytic 
approaches aligns with the research question of interest and that the data sources, study 
design elements, and analytic approaches were not selected to favor particular study 
findings. 
  
  To ensure transparency regarding their study design, sponsors should post their study 
protocols on a publicly available website, such as ClinicalTrials.gov13 or the web page for 
the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance 
(ENCePP) for post-authorization studies.14 
 
  In their final report, sponsors should describe the patient characteristics of the source 
population (i.e., the population from which the study population is drawn) and the study 
population (i.e., the population for which analyses are conducted) and should note any 
differences that may impact the final study findings.  
 
  In their final report, sponsors should document the analyses performed on the final 
dataset or datasets according to the SAP; any additional analyses should be described as 
exploratory. 
 
  Sponsors should enable and maintain audit trails of data, starting from extracting RWD 
sources through maintenance and retention of dataset(s).  This process should include the 
tracking of user access, data changes, changes to the protocol, and analyses performed.  
 
3.  Access to RWD 
 
  In the early stages of designing a non-interventional study intended for use in a marketing 
application, sponsors should discuss with the relevant review division the expectations 
regarding access to RWD used in their development program.  Sponsors must ensure that 
they are able to submit patient-level data for any RWD that have been analyzed as part of 
the clinical study included in a marketing application when required under 21 CFR 
314.50 and 601.2.  
 
  If certain RWD are owned and controlled by other entities, sponsors should have 
agreements in place with those entities to ensure that relevant patient-level data can be 
provided to FDA and that source data15 necessary to verify the RWD are made available 
for inspection as applicable.  
 
 
13 See https://www.clinicaltrials.gov.  For an interventional study that meets the definition of an applicable clinical 
trial, legal requirements exist for submission of certain information relating to the study.  See 42 CFR part 11. 
 
14 See https://www.ema.europa.eu/en. 
 
15 For the purposes of this guidance, source data include all information in original records and certified copies of 
original records of clinical findings, observations, or other activities in a clinical investigation used for 
reconstructing and evaluating the investigation.   
  6  Contains Nonbinding Recommendations 
  If an appropriate justification exists for why a sponsor cannot submit patient-level data to 
FDA through traditional channels, regulatory pathways exist for third parties to provide 
patient-level data to FDA to support a sponsors marketing application.  Specifically, the 
third-party provider can choose to open either a pre-investigational new drug application 
(pre-IND) or a Type V drug master file (DMF).  The sponsor should provide a letter of 
authorization from the third party for FDA to reference the data in a third partys pre-IND 
or DMF.  FDA does not currently accept links to external databases for such data.   
 
  Sponsors should ensure that RWD and associated programming codes and algorithms 
submitted to FDA are documented, well-annotated, and complete, which would allow 
FDA to replicate the study analysis using the same dataset and analytic approach.16 
 
4.  Study Monitoring  
 
  Study monitoring is one of the principal quality control activities critical to ensuring that 
(1) the study is conducted according to the protocol, (2) data submitted to FDA are 
reliable, and (3) data are appropriately protected.  For non-interventional studies, 
monitoring should begin at the data extraction from RWD sources and focus on the 
protection of human subjects, as applicable, and on maintaining data integrity.17 
 
  As part of study monitoring of a non-interventional study, sponsors should, at a 
minimum: 
 
  Ensure that the RWD required by the protocol are accurate and consistent with the 
source records 
 
  Ensure that prespecified plans (e.g., SAP), protocol, and study procedures (e.g., for 
curation and transformation and reporting of results) were followed 
 
  Ensure that deviations from the prespecified plans and protocol and study procedures 
are identified and documented, and when necessary, promptly evaluated and 
remediated according to the significance of the deviations that have been identified 
 
  FDA encourages sponsors to use a risk-based quality management approach to study 
oversight.18  This approach focuses sponsor oversight activities on (1) processes critical 
 
16 For further information, see the draft guidances for industry (1) Real-World Data: Assessing Electronic Health 
Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products 
(September 2021) and (2) Data Standards for Drug and Biological Product Submissions Containing Real-World 
Data (October 2021).  When final, these guidances will represent FDAs current thinking on these topics.  
 
17 For the purposes of this guidance, data integrity refers to the completeness, consistency, and accuracy of data; the 
data should also be attributable, legible, contemporaneously recorded, and an original or a certified copy. 
 
18 Additional considerations for risk-based monitoring practices that may be relevant for non-interventional study 
oversight can be found in (1) the guidance for industry Oversight of Clinical InvestigationsA Risk-Based 
Approach to Monitoring (August 2013), (2) the guidance for industry A Risk-Based Approach to Monitoring of 
 
  7  Contains Nonbinding Recommendations 
to human subject protection that are relevant when additional protocol-specified activities 
or procedures are included in a non-interventional study19 and (2) preventing or 
mitigating important and likely risks to study quality. 
 
5.  Safety Reporting  
 
  Applicants of NDAs and BLAs and other responsible parties are subject to regulatory 
requirements regarding postmarketing safety reporting.  Non-interventional studies 
examine the use of a drug in routine medical practice, and the Agency requires that 
applicants comply with postmarketing safety reporting regulations regarding the 
occurrence of relevant adverse events.20  
 
  For non-interventional studies, FDA recognizes that sponsors will often use only a subset 
(often called an analytic dataset) of a larger real-world dataset to conduct their analyses to 
support labeling changes.  For example, a larger dataset may contain information 
regarding a products approved and unapproved uses in clinical practice.  If the sponsor is 
conducting a study to support a specific labeling change (e.g., a new indication), FDA 
does not expect the sponsor to search the entire database regarding all uses of the product 
for adverse events that would meet the reporting requirements under FDAs 
postmarketing reporting regulations.  Nonetheless, if a sponsor identifies adverse events 
that are subject to postmarketing reporting requirements during the course of conducting 
a non-interventional study, such events must be reported in accordance with applicable 
postmarketing reporting requirements.21  
 
6.  Other Sponsor Responsibilities 
 
  For a marketing application containing data from a non-interventional study submitted to 
support regulatory decisions regarding the safety or effectiveness of a product, the 
 
Clinical Investigations:  Questions and Answers (April 2023), and (3) the ICH guidance for industry E6(R2) Good 
Clinical Practice:  Integrated Addendum to ICH E6(R1) (March 2018).  
 
19 When a non-interventional study includes additional protocol-specified activities and procedures, study 
monitoring should also ensure that applicable human subject protection requirements are met and data integrity is 
maintained.  See, e.g., 21 CFR 56.111, which includes as a criterion for IRB approval of research that the research 
plan, where appropriate, makes adequate provision for monitoring data collected to ensure the safety of subjects.  
 
20 See 21 CFR 314.80, 314.81, and 600.80. 
 
21 FDA recommends that applicants, at a minimum, have knowledge of the following four elements before 
considering any clinical incident for submission to FDA in an individual case safety report:  (1) an identifiable 
patient, (2) an identifiable reporter, (3) a suspect drug or biological product, and (4) an adverse experience or fatal 
outcome suspected to be due to the drug or biological product.  See the draft guidance for industry Postmarketing 
Safety Reporting for Human Drug and Biological Products Including Vaccines (March 2001).  When final, this 
guidance will represent FDAs current thinking on this topic.  Also see the guidance for industry Postmarketing 
Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application 
(July 2009) and the guidance for industry and FDA staff Postmarketing Safety Reporting for Combination Products 
(July 2019).  
  8  Contains Nonbinding Recommendations 
electronic systems used by the sponsor to manage the data and produce required records 
should comply with 21 CFR part 11.22   
 
  Sponsors who submit non-interventional studies for regulatory review should take 
responsibility for all activities related to the design, conduct (including data analysis), and 
oversight of the studies.  These activities should include, but not be limited to: 
 
  Selecting researchers qualified by training and experience to perform study-related 
activities and confirming that researchers have the skills and information needed to 
perform their roles in the study 
 
  Ensuring that the study is conducted in accordance with the final protocol and SAP 
and documenting any deviations 
 
  Maintaining and retaining adequate study records 
 
  Ensuring that FDA can access and verify relevant records (see section III.B.3 of this 
guidance for data access considerations) 
 
  Ensuring appropriate oversight of the study, including (when applicable) selecting a 
monitor qualified by training and experience 
 
  FDA expects that the sponsor will retain and make available to the Agency upon request 
a log of any researcher or researchers who have significant involvement in the design or 
conduct of the study.  The log should contain information on researchers, including: 
 
  Researchers name and affiliations 
 
  Description of roles or activities performed 
 
  Qualifications regarding education, training, and experience to perform the proposed 
study role 
 
  If sponsors engage third parties (e.g., data service providers or contract research 
organizations) to perform certain study-related tasks, sponsors should document the roles 
and responsibilities of the organization or organizations performing the tasks.  These 
documents should be made available to FDA upon request.  Sponsors should remain 
responsible for all study-related activities unless a sponsor has transferred its 
responsibility to a contract research organization. 
 
22 For further information, see (1) the guidance for industry Part 11, Electronic Records; Electronic Signatures  
Scope and Application (August 2003), (2) the draft guidance for industry Electronic Systems, Electronic Records, 
and Electronic Signatures in Clinical Investigations: Questions and Answers (March 2023) (when final, this 
guidance will represent FDAs current thinking on this topic), and (3) the guidance for industry Use of Electronic 
Health Record Data in Clinical Investigations (July 2018).  
  9