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

FDA May Seek More Authority To Require Post-Marketing Safety Studies

Executive Summary

FDA may consider asking for more authority to compel companies to undertake post-marketing drug safety studies after examining manufacturers' compliance with existing Phase IV commitments

You may also be interested in...



Post-Marketing Progress: Drug Industry Is Meeting Phase IV Commitments, FDA Says

FDA’s John Jenkins disputes accusations that the pharmaceutical industry does not take post-marketing studies seriously and that the agency is lax on enforcement. According to updated data from FDA, Phase IV studies are being completed in a timely manner, Jenkins argues – and when they aren’t, the agency is taking action.

Phase IV Studies Need Greater Input From FDA, Industry Tells IoM Panel

Drug manufacturers need more clarity from FDA regarding post-marketing studies, industry representatives told the Institute of Medicine's Committee on the Assessment of the U.S. Drug Safety System

Phase IV Studies Need Greater Input From FDA, Industry Tells IoM Panel

Drug manufacturers need more clarity from FDA regarding post-marketing studies, industry representatives told the Institute of Medicine's Committee on the Assessment of the U.S. Drug Safety System

Related Content

Topics

UsernamePublicRestriction

Register

PS046145

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