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
UsernamePublicRestriction

FDA Outlines Plans to Use Quality Metrics for Surveillance of Manufacturers

This article was originally published in The Gold Sheet

Executive Summary

Using new authorities granted under FDASIA, FDA would remotely collect data that’s available for inspection and analyze it based on standardized quality metrics, enabling its inspectorate to see which plants to visit and why. The agency could mandate participation but instead is offering an incentive: the regulatory flexibility that it didn’t deliver in return for quality by design.

You may also be interested in...



FDA Quality Metrics Proposal Sparks Objections, Disarray

Pharmaceutical manufacturers argued FDA can’t make them report quality metrics data, but there was little else they could agree on in their initial reaction to the complex, enforceable reporting scheme FDA has proposed in its draft quality metrics guidance.

User Fee Bill Puts Industry, FDA to Work on Supply Chain Risks

The user fee legislation Congress approved June 26 makes quality risk management a GMP requirement, further pressuring pharmaceutical manufacturers to make sure they are protecting their global supply chains. The bill directs FDA to inspect based on risk rather than time or location, and to rely on trusted foreign inspectorates, while adding new user fees for generic drugs that will boost funding for further expansion of the agency’s inspectorate.

Sponsors Fail To Win US FDA Endorsement For Trimming Trials During Pandemic

Agency more interested in switching to remote methods or imputing data than reducing sample size or duration of cell/gene therapy trials, official tells ASGCT.

Topics

UsernamePublicRestriction

Register

PS000761

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