27/28 September 2022
The U.S. Food and Drug Administration (FDA) has published a Draft Guidance for Industry entitled Collecting and Providing 702(b) Portions of FDA Official Samples. The 10-page document is intended to assist FDA staff and industry with issues and questions related to the requirements for FDA to collect and provide portions of official samples under section 702(b) of the Federal Food, Drug, & Cosmetic Act (FD&C Act).
According to the draft guidance, "FDA uses the term 702(b) portion to refer to the part of FDA’s official sample of a food, drug, or cosmetic that FDA is required to provide to the owner, upon request under section 702(b) of the FD&C Act. FDA will collect and provide a 702(b) portion in accordance with 702(b) of the FD&C Act and its implementing regulation in 21 CFR 2.10."
In the document, the following ten questions are answered:
The PDF-Version of the draft guidance is available following this link.
Online or written comments on any guidance can be submitted at any time. However, to ensure that the FDA considers the remarks on this draft guidance before beginning to work on the final version of the guidance, comments should be submitted until February 22, 2022.