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

US FDA Promises Shorter, Quicker Drug GMP Warning Letters

This article was originally published in SRA

Executive Summary

The US Food and Drug Administration is writing shorter drug GMP warning letters in an effort to issue them more quickly.

You may also be interested in...



User Fee Bill Or Drug Pricing Bill? House Members Makes Both Cases

House passes bill reauthorizing FDA user fee programs via voice vote and makes many other policy changes, but in the process touts the bill's potential to push drug prices lower.

US FDA’s New Compliance Chief Donald Ashley Brings International Law Enforcement Experience

Ashley's many years in the Department of Justice’s Office of International Affairs should be a plus for agency's globalization efforts.

FDA’s Teva Warning Letter Sets Agenda For Investigating, Remedying Sterility Failures

FDA has published a warning letter that not only provides detailed guidance for Teva’s ongoing remediation of sterility assurance failures at a plant in Godollo, Hungary, but also suggests a game plan for any manufacturer of sterile drug products that’s seeing signs of issues with aseptic operations.

UsernamePublicRestriction

Register

PS118712

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