Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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 Closeout "Carrots" Sprout; Baxter Receives First, But FDA Is Subdued

Executive Summary

If the first-ever FDA closeout letter to an Rx manufacturer is any indication, the correspondence may not offer a clear-cut end to compliance issues cited in warning letters

You may also be interested in...



FDA Policy Power Challenged In House Questions On Untitled Letters

Chairman Murphy wants to know if FDA is aware of consequences of publishing letters during stock trading hours.

GMP Close-out Letter Program Shows Few Benefits After 20 Months

More than 20 months after FDA Commissioner Margaret Hamburg announced with much fanfare that the agency would issue "close-out letters" to companies that had received FDA warning letters once they had addressed the problems inspectors found, the program has yet to fulfill its promise of offering sponsors a reliable, public way of resolving regulatory problems.

GMP Close-out Letter Program Shows Few Benefits After 20 Months

More than 20 months after FDA Commissioner Margaret Hamburg announced with much fanfare that the agency would issue "close-out letters" to companies that had received FDA warning letters once they had addressed the problems inspectors found, the program has yet to fulfill its promise of offering sponsors a reliable, public way of resolving regulatory problems.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS052074

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