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's Post-Market NME Safety Reviews "Useful," But May Not Continue

This article was originally published in The Pink Sheet Daily

Executive Summary

Evaluations lead to labeling changes but were resource-intensive, according to agency's final report on a pilot program involving five NMEs.

You may also be interested in...



NME Safety Reviews Expected For Three More Drugs, With FDA Pilot Program Expansion

Agency's decision means that analysis of Doribax, Isentress and Bystolic will be forthcoming.

NME Safety Reviews Expected For Three More Drugs, With FDA Pilot Program Expansion

Agency's decision means that analysis of Doribax, Isentress and Bystolic will be forthcoming.

FDA Safety Pilot Prompts SNRI Relabeling; “Too Soon To Tell” Patient Impact

FDA's pilot program to conduct post-market safety reviews of new molecular entities has catalyzed labeling changes for Lilly's Cymbalta, but its impact on patient safety remains uncertain

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS068602

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