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

Jury Still Out On Success Of FDA's Warning Letter Close-Out Program

This article was originally published in The Tan Sheet

Executive Summary

FDA is extending its warning letter "close-out" pilot program to learn more about its value, even as some experts grumble that the program may not be all it was cracked up to be.

You may also be interested in...



FDA Enforcement Follow-Through Could Thin Out Violators

FDA's emphasis on follow-through in its revamped enforcement strategy may help weed out bad actors from legitimate industry

Industry Involvement In Guidance Development Encouraged By FDA Working Group

In a report on best practices for guidance development, FDA encourages outside groups to submit their own draft guidance proposals to help make the overall process more efficient.

FDA’s Office Of Regulatory Affairs Scrutinizes Recalls Process

ORA sets a 2012 priority of improving the efficiency of the recall process to help reach its overall enforcement and compliance goal of preventing public health emergencies.

Topics

UsernamePublicRestriction

Register

PS105099

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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