2022-20523: How To Obtain a Covered Product Authorization; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "How To Obtain a Covered Product Authorization." 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. 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 a CPA from the Agency. This guidance replaces the December 2014 draft guidance for industry "How To Obtain a Letter From FDA Stating That Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD," which has been withdrawn. This draft guidance is not final nor is it in effect at this time.
The agency’s own summary, as published.
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