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

FDA Drug Safety Committee To Discuss Use Of Post-Marketing Studies May 19

This article was originally published in The Pink Sheet Daily

Executive Summary

The Drug Safety & Risk Management Advisory Committee will consider the utility of various types of post-market studies in detecting and quantifying risk.

You may also be interested in...



Drug Safety Surveillance Based On Medicare Data Should Top List Of FDA Priorities

Implementation of the Medicare drug benefit provides an opportunity for an active surveillance system to collect drug safety data, Drug Safety & Risk Management Advisory Committee members say. Active surveillance can act as a safety net for FDA's adverse events signaling system.

NDAs Should Include More Cross-Study Analysis, FDA Says In Draft Guidance

FDA is clarifying that it expects sponsors to provide analysis of efficacy data rather than simply a summary of clinical data as part of the integrated summary of effectiveness in new drug applications

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS062227

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