Placeholder Banner

BIO Comments on FDA Draft Guidance on Product Identifiers Under the Drug Supply Chain Security Act Q&A

November 19, 2018

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance for Industry, Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers.

BIO member companies are committed to ensuring the U.S. drug supply chain is secure, patients are receiving authentic products, and legitimate medications continue to move through the supply chain without unnecessary delays. The Drug Supply Chain Security Act (DSCSA) will improve the security of the U.S. pharmaceutical supply chain only with collaboration among all supply-chain stakeholders.

In the comments, BIO says this Q&A document will help sponsors and stakeholders better understand the use of product identifiers. BIO provides suggestions on how to make the guidance more clear and effective, regarding the order and format of product identifier requirements, expiration date formatting, use of the GTIN and NDC, and the timely release of guidance documents.

 

Download Full Comments Below
2018-11-19 BIO Comments On Product Identifers Under DSCSA QA FINAL
Read full comment letter below
Discover More
We write as a coalition of advocates for the startup ecosystem to voice our strong support for the IGNITE American Innovation Act, legislation to support startups through the economic crisis by allowing companies to monetize tax assets generated…
The Biotechnology Innovation Organization (BIO) is pleased to respond to the U.S. Department of Agriculture’s (USDA) Solicitation of Input from Stakeholders on Agricultural Innovations. BIO applauds USDA for taking a proactive approach and seeking…
July 31, 2020 Re: Docket No. FDA–2020-N-0837: Raare Disease Clinical Trial Network; Request for Information. Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the…