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

Industry Responds to FDA’s Quality Metrics Initiative with Proposal to Report Trends, not Values

This article was originally published in The Gold Sheet

Executive Summary

Industry, FDA explore why manufacturers should report absolute value of quality metrics, not just the trends. FDA’s Woodcock suggests potential reward of reduced inspections by not only FDA, but also by other inspectorates.

You may also be interested in...



After Recusal, Schnedar Leaving CDER Compliance Office

Cynthia Schnedar decides to leave several weeks after FDA determined that her husband's promotion could create conflicts of interest.

FDA GMP “Surveillance” Will Link Quality, Compliance Information To Inspections

CDER’s Woodcock says the new database will drive risk-based inspection decisions.

Biden Launches Effort To Strengthen US Pharmaceutical Supply Chain

A fresh executive order from US president Joe Biden calls for short-term and long-term study, broad consultation, and co-ordination with allies on the domestic supply chain.

Topics

UsernamePublicRestriction

Register

OM009724

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