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 GMP Initiative Shifts Warning Letter Review Back To Agency Centers

Executive Summary

The Center for Drug Evaluation & Research will begin reviewing GMP warning letters March 1 as part of an FDA initiative to create a risk-based approach to pharmaceutical manufacturing

You may also be interested in...



Hamburg Offers Warning Letter "Close-Out" In Plan To Speed Enforcement

FDA Commissioner Margaret Hamburg is including a carrot for industry - a warning letter close-out process - in a multi-stick initiative to strengthen the agency's enforcement program

Hamburg Offers Warning Letter "Close-Out" In Plan To Speed Enforcement

FDA Commissioner Margaret Hamburg is including a carrot for industry - a warning letter close-out process - in a multi-stick initiative to strengthen the agency's enforcement program

Hamburg Offers "Close Out" Carrot To Firms In Plan To Accelerate Enforcement

FDA enforcement initiative eliminates requirement for all warning letters to be reviewed by Office of Chief Counsel.

Related Content

UsernamePublicRestriction

Register

PS041309

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