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How To Obtain a Covered Product Authorization September 2022


Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2022-D-1358

Docket Number:
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Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance describes how eligible product developers can obtain a Covered Product Authorization (CPA) from FDA under the law widely known as the CREATES Act (referred to herein as CREATES or the CREATES Act). The CREATES Act provides a pathway for eligible product developers to obtain access to the product samples they need to fulfill testing and other regulatory requirements to support their applications. As described in further detail below, to make use of this pathway, an eligible product developer seeking to develop a product subject to a Risk Evaluation and Mitigation Strategies (REMS) with elements to assure safe use (ETASU) must obtain from the Agency a Covered Product Authorization (see 21 U.S.C. 355-2(b)(2)). This guidance replaces the December 2014 draft guidance for industry How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD. The December 2014 guidance has been withdrawn.

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