GMP Third-Party Audits Offered In Draft Senate User Fee Legislation
This article was originally published in The Pink Sheet Daily
Bipartisan group of senators unveils several draft provisions of user fee legislation, including a program to allow third-party auditors to evaluate manufacturing facility compliance with U.S. standards for drugs.
You may also be interested in...
Latest version of potential House user fee bill eliminates revisions to FDA’s mission statement and includes provisions for approving breakthrough technologies and destroying unsafe drug imports at the border.
The Senate user fee bill may get industry’s version of track-and-trace or FDA’s or neither, but certainly would free FDA from inspecting facilities every two years. Meanwhile, Congress keeps generating ideas for combating drug shortages.
Sens. Bennet and Burr file amendment to implement the industry-backed RxTEC proposal, which would require serialization, but is not a full track-and-trace system and is not supported by FDA.