BIO Comments on FDA Draft Guidance on Product Identifiers Under the Drug Supply Chain Security Act Q&A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BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance for Industry, Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers.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
One thing that we can all agree on is the need to give our children a fighting chance so they can lead long and productive lives. That is why it is critical to pass the bipartisan Give Kids a Chance Act and ensure the Pediatric Priority Review…
Dear Colleagues, This month marks my one-year anniversary as BIO's CEO. Like most of us in biotech, this post has been a labor of love. At no time in my 25-year career in this industry have I ever witnessed such awe-inspiring science. Today, we…
Re: BIO Comments on Office of Management and Budget (OMB) Statistical Policy Directive No. 8 North American Industry Classification System (NAICS)-Request for Comments on Possible Revisions for 2027 (USBC–2024–0032)Dear Ms. Orvis,The Biotechnology…
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance for Industry, Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers.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.