Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

GMP Third-Party Audits Offered In Draft Senate User Fee Legislation

This article was originally published in The Pink Sheet Daily

Executive Summary

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...



PDUFA Stars Aligning As House Draft Gives FDA Direct Authority Over Importers

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.

Legislation in Brief

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.

Track and Trace Battle Looms At Senate User Fee Mark-Up

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.

Related Content

Topics

UsernamePublicRestriction

Register

PS073890

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel