How To Obtain a 
Covered Product 
Authorization 
 
 
 
Guidance for Industry 
 
 
 
DRAFT GUIDANCE 
 
  This guidance document is being distributed for comment purposes only. 
 
Comments and suggestions regarding this draft document should be submitted within 60 days of 
publication in the Federal Register of the notice announcing the availability of the draft 
guidance.  Submit electronic comments to https://www.regulations.gov.  Submit written 
comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD  20852.  All comments should be identified with the 
docket number listed in the notice of availability that publishes in the Federal Register. 
 
For questions regarding this draft document, contact CPAguidance@fda.hhs.gov. 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
September 2022 
Procedural 
 
   
How To Obtain a 
Covered Product 
Authorization 
 
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  
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs  
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 September 2022 
Procedural 
 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
TABLE OF CONTENTS 
 
 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 1 
A.  Relevant Product Types ................................................................................................................ 2 
1. Generic Drug Products .................................................................................................................... 2 
2. 505(b)(2) Products ........................................................................................................................... 3 
3. Biosimilar Products ......................................................................................................................... 3 
B.  Need for Brand Product Samples to Support Product Applications ........................................ 4 
III.  PASSAGE OF THE CREATES ACT ............................................................................. 5 
A. Key Terms in CREATES .................................................................................................................. 5 
B. Covered Product Authorizations Under CREATES ...................................................................... 6 
IV.   HOW TO OBTAIN A COVERED PRODUCT AUTHORIZATION FROM FDA .. 7 
We recommend that interested developers seeking CPAs submit their requests as follows: .......... 7 
A.  Contents of a CPA Request ........................................................................................................... 7 
B.  FDA Review .................................................................................................................................... 8 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
1  How to Obtain a Covered Product Authorization  
2  Guidance for Industry1 
3   
4   
5  This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
6  Administration (FDA or Agency) on this topic.  It does not establish any rights for any person 
7  and is not binding on FDA or the public.  You can use an alternative approach if it satisfies the 
8  requirements of the applicable statutes and regulations.  To discuss an alternative approach, 
9  contact the FDA staff responsible for this guidance as listed on the title page.   
10   
11   
12   
13  I.  INTRODUCTION  
14   
15  This guidance describes how eligible product developers can obtain a Covered Product 
16  Authorization (CPA) from FDA under the law widely known as the CREATES Act (referred to 
17  herein as CREATES or the CREATES Act).  The CREATES Act provides a pathway for eligible 
18  product developers to obtain access to the product samples they need to fulfill testing and other 
19  regulatory requirements to support their applications.  As described in further detail below, to 
20  make use of this pathway, an eligible product developer seeking to develop a product subject to a 
21  Risk Evaluation and Mitigation Strategies (REMS) with elements to assure safe use (ETASU) 
22  must obtain from the Agency a Covered Product Authorization (see 21 U.S.C. 355-2(b)(2)).  
23  This guidance replaces the December 2014 draft guidance for industry How to Obtain a Letter 
24  from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable 
25  to Applicable REMS for RLD.  The December 2014 guidance has been withdrawn.   
26  The contents of this document do not have the force and effect of law and are not meant to bind 
27  the public in any way, unless specifically incorporated into a contract.  This document is 
28  intended only to provide clarity to the public regarding existing requirements under the law. 
29  FDA guidance documents, including this guidance, should be viewed only as recommendations, 
30  unless specific regulatory or statutory requirements are cited.  The use of the word should in 
31  Agency guidance means that something is suggested or recommended, but not required. 
32   
33  II.  BACKGROUND 
34  In December of 2019, the CREATES Act was enacted as part of the Further Consolidated 
35  Appropriations Act of 2020.2  As noted above, CREATES makes available a pathway for 
 
1 This guidance has been prepared by the Office of Regulatory Policy, the Office of Generic Drugs, and the Office 
of New Drugs in the Center for Drug Evaluation and Research at the Food and Drug Administration.  
2 See P.L. 116-94 (Further Consolidated Appropriations Act, 2020, enacting Division N, Title I, Subtitle F, Section 
610Actions for Delays of Generic Drugs and Biosimilar Biological Products (Dec. 20, 2019)).  The provisions of 
this law related to access to product samples were codified at 21 U.S.C. 355-2 and 355-1(l). 
  1  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
36  developers of potential drug and biological products to obtain samples3 of brand products4 that 
37  they need to support their applications.  CREATES establishes a private right of action that 
38  allows eligible product developers5 to sue brand companies that refuse to sell them product 
39  samples needed to support their applications.  If the product developer prevails, the court will 
40  order the sale of samples, will award attorneys fees and litigation costs to the product developer, 
41  and may impose a monetary penalty on the brand company. 
42  If a product developer is not able to obtain samples of the brand product that they need to support 
43  their application from the brand company on a voluntary basis and seeks to use the pathway 
44  made available by CREATES, they must take a number of specific steps (outlined in the law) 
45  before the brand company will be required to sell them product samples under CREATES.  One 
46  of these steps  if the brand product for which samples are sought is subject to a Risk Evaluation 
47  and Mitigation Strategy (REMS) with elements to assure safe use (ETASU)6  is that the product 
48  developer must first obtain a Covered Product Authorization (CPA) from FDA (21 U.S.C. 355-
49  2(b)(2)).7  CREATES does not require this step for products that are not subject to REMS with 
50  ETASU.  This guidance describes how an eligible product developer can obtain a CPA from 
51  FDA.  
52   
53  A.  Relevant Product Types 
54   
55  1.  Generic Drug Products  
56   
57  The Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman 
58  Amendments) created section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
59  (21 U.S.C. 355(j)), which established the current abbreviated new drug application (ANDA) 
60  approval process for generic drugs.  To obtain approval to market a generic drug, an ANDA 
61  applicant is not required to submit clinical studies to establish the safety and effectiveness of the 
62  proposed generic drug product, but instead may rely on the Agencys previous finding of safety 
63  and effectiveness for the reference listed drug (RLD).  To do so, an ANDA applicant generally 
 
3 As used in this guidance, the terms samples and product samples refer to an amount of a covered product as 
defined by 21 U.S.C. 355-2(a)(2) that the eligible product developer determines allows it to conduct testing to 
support certain types of applications and fulfill any regulatory requirements relating to approval of such 
applications.   
4 As used in this guidance, the term brand product refers to the statutory term covered product as defined by 
U.S.C. 355-2(a)(2), which include drugs approved under section 505(c) or (j) of the Federal Food, Drug and 
Cosmetic Act or biological products licensed under section 351(a) or (k) of the Public Health Service Act.  In 
addition, the term brand company, as used in this guidance, refers to the statutory term license holder, as 
defined by 21 USC 355-2(a)(5). 
5 See definitions in section III.A.  Note that this guidance also refers to eligible product developers as product 
developers. 
6 FDAs online listing of approved REMS is available 
at https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm. Product developers should check this listing to 
confirm that the product for which they seek a CPA is covered by a REMS with ETASU before submitting a CPA 
request.   
7 Note that requesting or obtaining a CPA from FDA is not a legal requirement to obtain samples of a covered 
product, and the process described in this guidance is voluntary and applies only to those who seek to avail 
themselves of the CREATES pathway to obtain such samples.  CREATES also provides a pathway for obtaining 
samples of covered products that are not subject to REMS with ETASU. 21 U.S.C. 355-2. 
  2  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
64  must demonstrate, among other things, that the proposed generic drug product (1) has the same 
65  active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with 
66  certain exceptions) labeling as the reference listed drug (RLD), and (2) is bioequivalent to the 
67  RLD (see section 505(j)(2)(A) of the FD&C Act).  Bioequivalence is generally demonstrated via 
68  studies in which the proposed generic product is compared to the RLD.  
69   
70  2.  505(b)(2) Products 
71   
72  Section 505(b)(2) of the FD&C Act represents another abbreviated approval pathway added by 
73  the Hatch-Waxman Amendments.  As background, a stand-alone new drug application (NDA) 
74  submitted under section 505(b)(1) contains full reports of investigations of safety and 
75  effectiveness that were conducted by or for the applicant or for which the applicant has a right of 
76  reference or use (see 21 U.S.C. 355(b)(1), (c)).  A 505(b)(2) application, meanwhile, is an 
77  NDA that also contains full reports of investigations of safety and effectiveness, but for which 
78  one or more of the investigations relied upon by the applicant for approval were not conducted 
79  by or for the applicant and for which the applicant has not obtained a right of reference or use 
80  from the person by or for whom the investigations were conducted (21 U.S.C. 355(b)(2)).  A 
81  505(b)(2) application may be submitted to seek approval for, among other things, a new 
82  chemical entity, or for a change to an approved drug that would not be permitted under section 
83  505(j).  A 505(b)(2) application should include, among other things, an identification of those 
84  portions of the application that rely on information the applicant does not own or to which the 
85  applicant does not have a right of reference.  If the 505(b)(2) seeks to rely on the Agencys 
86  previous finding of safety or efficacy for a listed drug, or on literature derived from studies of a 
87  listed drug or drugs, a 505(b)(2) application should also include, among other things, a 
88  bioavailability/bioequivalence study comparing the proposed product to the listed drug or drugs 
89  and studies necessary to support any change or modification from the listed drug or drugs, if any.   
90   
91  3.  Biosimilar Products 
92   
93  The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) amended the Public 
94  Health Service Act (PHS Act) to create an abbreviated licensure pathway for biological products 
95  shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product 
96  (see sections 7001 through 7003 of the Patient Protection and Affordable Care Act (Public Law 
97  111148)).  Section 351(k) of the PHS Act (42 U.S.C. 262(k)), added by the BPCI Act, sets forth 
98  the requirements for the licensure of a proposed biosimilar or a proposed interchangeable 
99  biosimilar.  An application submitted under section 351(k) must contain, among other things, 
100  information demonstrating that the biological product is biosimilar to a reference product8 based 
101  upon data derived from analytical studies, animal studies, and a clinical study or studies (see 
102  section 351(k)(2)(A)(i)(I) of the PHS Act).  FDA has the discretion to determine that an element 
103  is unnecessary in a 351(k) application.  In addition, FDA expects that applications for 
104  interchangeable biosimilars generally will include data from a switching study or studies, 
105  meaning a clinical study or studies used to determine the impact of alternating or switching 
 
8  Under section 351(i)(4) of the PHS Act, the term reference product means the single biological product licensed 
under section 351(a) of that Act, against which a biological product is evaluated in a 351(k) application. 
 
  3  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
106  between the proposed interchangeable product and the reference product, in one or more 
107  appropriate conditions of use.9 
108   
109  B.  Need for Brand Product Samples to Support Product Applications 
110   
111  To conduct the studies and testing described above to support their applications, ANDA, 
112  505(b)(2) and biosimilar product applicants typically need access to some amount of the brand 
113  product.  Other testing (such as that necessary to establish the appropriate dissolution 
114  specifications for a proposed product) and/or regulatory requirements (such as those relating to 
115  the retention of reserve samples) may require an applicant to obtain additional supplies of the 
116  brand product to support their applications.  The amount of product needed will depend on, 
117  among other things, the scientific requirements of such studies and testing, including, where 
118  appropriate, the number of lots necessary to provide adequate information regarding brand 
119  product variability, and on applicable regulatory requirements. 
120  Often, product developers are able to obtain these product samples needed to support their 
121  application through normal distribution channels (e.g., via wholesalers).  Sometimes, however, 
122  samples of the brand product are not available through normal distribution channels.  A product 
123  may not be available through standard distribution channels because the brand company limits its 
124  distribution (for example, by selling it through a central or small group of pharmacies) on its own 
125  initiative.  In other cases, a Risk Evaluation and Mitigation Strategy (REMS) with elements to 
126  assure safe use (ETASU) might impact the way the product is distributed.  
127  A REMS is a required risk management plan that uses tools beyond the prescribing information 
128  to ensure that the benefits of a drug outweigh its risks (section 505-1 of the FD&C Act).  FDA 
129  may require a REMS with ETASU when such elements are necessary to mitigate specific serious 
130  risks associated with a particular drug (section 505-1(f) of the FD&C Act).  ETASU may 
131  include, for example, requirements that health care providers who prescribe or administer the 
132  drug have particular training or are specially certified, that patients using the drug be monitored 
133  and/or enrolled in a registry, that pharmacies, practitioners, or health care settings that dispense 
134  the drug be specially certified, that the drug be dispensed to patients with evidence or other 
135  documentation of safe use conditions, or that the drug be dispensed to patients only in certain 
136  health care settings.  A REMS with ETASU might impact the way a product is distributed if, for 
137  example, only a limited number of pharmacies are willing and/or able to meet the specific 
138  pharmacy certification requirements in a REMS. 
139  Once such distribution limitations are in place (whether they are voluntarily imposed or related 
140  to REMS requirements) FDA understands that some product developers have encountered 
141  difficulty obtaining product samples from brand companies because brand companies have (1) 
142  refused to sell the product directly to developers (or imposed terms on the sale that developers 
143  found burdensome or impossible to comply with), or (2) placed limitations on the ability of 
144  pharmacies or wholesalers to sell samples to the companies for development purposes.  As a 
 
9 See guidance for industry, Considerations in Demonstrating Interchangeability With a Reference Product (May 
2019). 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-fdaguidance-documents. 
  4  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
145  result, protracted and/or unsuccessful efforts to obtain brand product samples slowed, prevented, 
146  or deterred development of competing versions of these products.   
147   
148  III.  PASSAGE OF THE CREATES ACT 
149  In December of 2019, CREATES was enacted to address these issues by providing a pathway for 
150  developers of ANDA, 505(b)(2), and biosimilar products to obtain needed product samples to 
151  support their applications.  CREATES established a private right of action that allows an eligible 
152  product developer to bring suit in an appropriate U.S. district court alleging that the license 
153  holder (i.e., the brand company) has declined to provide them with sufficient quantities of the 
154  covered product on commercially reasonable, market-based terms.   
155  A. Key Terms in CREATES 
156  The law defines the terms used above as follows:10 
157  Eligible product developer:  
158  a person that seeks to develop a product for approval pursuant to an application for 
159  approval under subsection (b)(2) or (j) of section 505 of the Federal Food, Drug, and 
160  Cosmetic Act (21 U.S.C. 355) or for licensing pursuant to an application under section 
161  351(k) of the Public Health Service Act (42 U.S.C. 262(k)) 
162   
163  License holder:  
164  the holder of an application approved under subsection (c) or (j) of section 505 of the 
165  Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or the holder of a license under 
166  subsection (a) or (k) of section 351 of the Public Health Service Act (42 U.S.C. 262) for a 
167  covered product 
168   
169  Sufficient quantities:  
170  an amount of a covered product that the eligible product developer determines allows it 
171  to (A) conduct testing to support an application under (i) subsection (b)(2) or (j) of 
172  section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355); or (ii) section 
173  351(k) of the Public Health Service Act (42 U.S.C. 262(k)); and (B) fulfill any regulatory 
174  requirements relating to approval of such an application 
175   
176  Covered product:  
177  (i) any drug approved under subsection (c) or (j) of section 505 of the Federal Food, 
178  Drug, and Cosmetic Act (21 U.S.C. 355) or biological product licensed under subsection 
179  (a) or (k) of section 351 of the Public Health Service Act (42 U.S.C. 262);  
180  (ii) any combination of a drug or biological product described in clause (i); or  
181  (iii) when reasonably necessary to support approval of an application under section 505 
182  of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), or section 351 of the 
183  Public Health Service Act (42 U.S.C. 262), as applicable, or otherwise meet the 
 
10 21 U.S.C. 355-2(a). 
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184  requirements for approval under either such section, any product, including any device, 
185  that is marketed or intended for use with such a drug or biological product. 
186   
187  The term covered product does not include any drug or biological product that appears 
188  on the drug shortage list in effect under section 506E of the Federal Food, Drug, and 
189  Cosmetic Act (21 U.S.C. 356e), unless  
190  (i)  the drug or biological product has been on the drug shortage list in effect under 
191  such section 506E continuously for more than 6 months; or  
192  (ii)  the Secretary determines that inclusion of the drug or biological product as a 
193  covered product is likely to contribute to alleviating or preventing a shortage.  
194  Commercially reasonable, market-based terms:  
195  (A) a nondiscriminatory price for the sale of the covered product at or below, but not 
196  greater than, the most recent wholesale acquisition cost for the drug, as defined in section 
197  1847A(c)(6)(B) of the Social Security Act (42 U.S.C. 1395w3a(c)(6)(B));  
198  (B) a schedule for delivery that results in the transfer of the covered product to the 
199  eligible product developer consistent with the timing under [subsection (b)(2)(A)(iv) of 
200  CREATES]; and  
201  (C) no additional conditions are imposed on the sale of the covered product 
202   
203  B. Covered Product Authorizations Under CREATES 
204   
205  To prevail in the private right of action established by CREATES, the eligible product developer 
206  must prove that it has taken a number of specific steps.  It must show, among other things, that it 
207  submitted a written request to the license holder to purchase sufficient quantities of the covered 
208  product, and that the request (1) was sent to a named corporate officer of the license holder, (2) 
209  was made by certified/registered mail with return receipt requested, (3) specified an individual 
210  point of contact and a means for written and electronic communication with them, and (4) 
211  provided a delivery address for samples.11  The eligible product developer must also prove that 
212  the license holder did not deliver sufficient quantities of the covered product on commercially 
213  reasonable, market-based terms within 31 days of receiving the request (for non-REMS ETASU 
214  products) or (for REMS ETASU products) within 31 days of receiving either the request OR a 
215  copy of the Covered Product Authorization (CPA), whichever is later.12 
216   
217  The CPA is a document obtained by the eligible product developer from FDA.  
218  CREATES provides that [a]n eligible product developer may submit to [FDA] a written 
219  request for the eligible product developer to be authorized to obtain sufficient quantities 
220  of an individual covered product subject to a REMS with ETASU.13  The law requires 
221  that FDA must respond to this request within 120 days.14 
222   
 
11 21 U.S.C. 355-2(b)(2)(A)(iii). 
12 21 U.S.C. 355-2(b)(2)(A)(iv). 
13 21 U.S.C. 355-2(b)(2)(B). 
14 Id.  
  6  Contains Nonbinding Recommendations 
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223  CPAs are only available for products that are subject to a REMS with ETASU.  To prevail in the 
224  private right of action established by CREATES, an eligible product developer seeking samples 
225  of a product that is not subject to a REMS with ETASU does not need to obtain a CPA.  
226   
227  In addition, the CPA established by CREATES replaces the Safety Determination Letter that 
228  FDA had been issuing prior to CREATES as described in the withdrawn draft guidance for 
229  industry How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain 
230  Safety Protections Comparable to Applicable REMS for RLD.  The purpose of the Safety 
231  Determination Letter was to provide RLD sponsors with written assurance that providing 
232  samples to a potential applicant would not be considered a violation of their REMS.  The CPA 
233  provides the same written assurance.  Note that unlike Safety Determination Letters, which FDA 
234  sent to the RLD sponsor at the prospective ANDA applicants request, CREATES provides that 
235  the eligible product developer is responsible for providing a copy of the CPA to the applicable 
236  license holder.15 
237   
238  IV.   HOW TO OBTAIN A COVERED PRODUCT AUTHORIZATION FROM FDA  
239   
240  We recommend that interested developers seeking CPAs submit their requests as follows: 
241   
242    For generic products, submit the request as a controlled correspondence to the CDER 
243  NextGen Collaboration Portal16 (general questions may be submitted 
244  to GenericDrugs@fda.hhs.gov). 
245    For 505(b)(2) products and biological products, submit the request to your pIND file 
246  or IND (with a copy to the related marketing application, if there is one).  If you do 
247  not have a pIND or IND number, request a file number as described at 
248  https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/requesting-
249  pre-assigned-application-number and submit the request to that numbered file. Please 
250  also email a copy of your CPA request to ONDCommunications@fda.hhs.gov. 
251   
252  A.  Contents of a CPA Request 
253   
254    Please prominently identify the request as a REQUEST FOR COVERED 
255  PRODUCT AUTHORIZATION.  Requests should specify that the product 
256  developer is seeking a CPA and the product for which a CPA is being sought.  
257    If the samples will be used for purposes of development and testing that involve 
258  human clinical trials, requests should be accompanied by study protocols, informed 
259  consent documents, and informational materials for testing demonstrating that safety 
260  protections comparable to those in the REMS for the brand product will be provided 
261  for in the study or studies for which samples are sought.  
262    If the samples will be used for purposes of development and testing that does not 
263  involve any testing in humans, the request should state that the samples will not be 
 
15 21 U.S.C. 355-2(b)(2)(A)(i). 
16 For more information, see guidance for industry, Controlled Correspondence Related to Generic Drug 
Development (Dec. 2020). 
  7  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
264  used for testing in humans. If you receive a CPA for development and testing that 
265  does not involve testing in humans and your development plan subsequently changes 
266  such that product samples are needed for human clinical trials, you should obtain a 
267  new CPA for these purposes.17  
268    If you seek a CPA for a product that is on the drug shortage list in effect under section 
269  506E of the Federal Food, Drug & Cosmetic Act (in shortage), please specify in 
270  your request that the product is on the drug shortage list.18 
271  CREATES does not impose limitations on the number of times an eligible product developer 
272  may request samples pursuant to a particular CPA or on the number of requests an eligible 
273  product developer may make for product samples to support their application. 
274  B.  FDA Review 
275   
276    The Agency will review any draft protocol(s), informed consent document(s), and 
277  informational materials submitted.  As the Agency processes your request for a CPA, we 
278  may ask for additional information via an information request.  
279    If the Agency determines that the protocols, informed consent documents, and 
280  informational materials for testing contain safety protections comparable to those 
281  provided by the applicable REMS with ETASU, FDA will issue a CPA letter within 120 
282  days of the date of submission.19 
283    If the drug is in shortage, FDA will determine whether (1) it has been in shortage 
284  continuously for more than six months, or (2) its inclusion as a covered product is likely 
285  to contribute to alleviating or preventing a shortage.  If the answer to either is yes, the 
286  Agency will issue a CPA to the requester, assuming the requester has met the remaining 
287  requirements for obtaining a CPA.  If not, the drug would not be considered a covered 
288  product under CREATES, and the CPA request will be rejected.20  If a CPA request is 
289  rejected on this basis, FDA recommends that the eligible product developer continue to 
290  monitor FDAs drug shortage list and consider submitting a new CPA after the product is 
291  either no longer in shortage or has been in shortage continuously for more than six 
292  months. 
293    If FDA cannot determine from the protocols, informed consent documents, and 
294  informational materials for testing submitted with your CPA request that safety 
295  protections comparable to those provided by the applicable REMS with ETASU will be 
296  provided, and the deficiencies in the materials submitted are more significant than can be 
297  resolved via an information request, your CPA request will be rejected and the reasons 
298  for rejection specified in the response.  The Agency intends to process any resubmission 
299  on a new 120-day clock. 
300   
 
17 See 21 U.S.C.  355-2(b)(2)(B)(ii). 
18 For more information, see https://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages. 
19 21 U.S.C. 355-2(b)(2)(B)(ii). 
20 Id.; 21 U.S.C. 355-2(a)(2)(B). 
  8