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

Re-release of Drug Watch guidance

Executive Summary

FDA expects to release its revised Drug Watch guidance "very soon," according to CDER Director Steven Galson. "We're very close to completing the guidance that responds to the initial draft we put out and comes up with decisions on each of those questions that were raised," Galson says Sept. 22. The original plans for a website for posting emerging risk information drew intense criticism, prompting FDA to redraft the guidance (1"The Pink Sheet" Feb. 21, 2006, p. 5)...

You may also be interested in...



Boxed Warnings, Drug Watch Are Policy Goals Of Drug Safety Oversight Board

FDA's Drug Safety Oversight Board should start shifting its focus toward broader policy questions - like standards for boxed warnings - in addition to addressing emerging safety issues for specific products, DSOB Executive Director Susan Cummins suggested

Cosmetic And Personal Care Trademark Review: 16 April

Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.

Health And Wellness Weekly Trademarks Review: 16 April

Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.

Latest Headlines
See All
UsernamePublicRestriction

Register

PS047629

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