How to Obtain a Covered Product Authorization

On 21 September 2022 the FDA published the draft guidance for industry. Submit comments by 21 November 2022.

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.

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