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BIO Comments on FDA Draft Guidance on Product Identifiers Under the Drug Supply Chain Security Act Q&A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BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance for Industry, Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers.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
On November 9, BIO submitted comments on the FDA Draft Guidance, Drug-Drug Interaction Assessment for Therapeutic Proteins. In the comments, BIO thanks the FDA for the opportunity to submit comments but requests that the Guidance include a…
On August 6, BIO submitted comments on the NMPA Draft Technical Guideline on Clinical Trials of Cellular Immunotherapy Products. In the comments, BIO thanks NMPA for the opportunity to submit comments but argues for a more robust commenting period…
October 30, 2020 Re: Docket No. FDA–2020-D-1564: FDA Draft Guidance, Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation. Dear Sir/Madam: The Biotechnology…