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 Approval Decisions Changing In Light Of Relabeling Failures - Woodcock

Executive Summary

FDA is not approving some prescription drugs because of a lack of confidence in labeling restrictions to ensure appropriate prescribing behavior, Center for Drug Evaluation & Research Director Janet Woodcock, MD, said during a National Public Radio interview Dec. 19.

You may also be interested in...



FDA Handling Of Antidepressant Inquiry “Troubles” Senate Investigators

The Senate Finance Committee is asking for contact information for former employees of FDA's Office of Drug Safety in its continuing investigation into the agency's handling of information on a possible link between antidepressants and suicide

FDA Handling Of Antidepressant Inquiry “Troubles” Senate Investigators

The Senate Finance Committee is asking for contact information for former employees of FDA's Office of Drug Safety in its continuing investigation into the agency's handling of information on a possible link between antidepressants and suicide

Phase IV Commitments For Registries Likely To Increase, Genentech Says

Manufacturers should expect more postmarketing commitments for safety and pregnancy exposure registries for chronic disease medications, Genentech Senior Epidemiologist Haley Kaplowitz, PhD, said during the Drug Information Association conference on pharmacovigilance in Washington, D.C. Jan. 14

Related Content

UsernamePublicRestriction

Register

PS037094

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