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

White House Mulls Proposal To Pause FDA's Quality Metrics Initiative

Executive Summary

Trump administration briefing materials show that the pharmaceutical industry's complaints about FDA's quality metrics initiative are getting high-level attention.

You may also be interested in...



Providers Support FDA Quest For Public Drug Manufacturing Quality Ratings

Agency agrees with those who prescribe and buy drugs on need to incentivize quality. Except providers want it yesterday.

FDA's Kopcha Presses Ahead On Quality Metrics Despite Industry Pushback

The head of US FDA's drug quality office, Michael Kopcha, rebukes industry pushback that got White House's ear and demands more constructive feedback on quality metrics. Industry workshop participants come up with creative ideas, but FDA finds them problematic. Asked whether industry should dive in or wait and see on voluntary phase of metrics initiative that begins in January, another FDA official says, "That's a tough one."

FDA Cites Lupin For Poor Quality Metric Performance

Indian firm's invalidated out-of-specification rate was too high, FDA suggests in heavily redacted Form 483 report. This rate, which also came up in two recent warning letters, happens to be one of the three rates the USagency wants to use as quality metrics for deciding how soon investigators should revisit sites.

Related Content

Topics

UsernamePublicRestriction

Register

LL1134531

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