Medtech Insight 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 REFORM LANGUAGE ENFORCING PMA REVIEW IN 180 DAYS DROPPED FROM FINAL BILL; ANNUAL REPORT PROVISION DOES NOT REQUIRE EXPLANATION OF OVERDUE PMAs

This article was originally published in The Gray Sheet

Executive Summary

Changes to the premarket approval application provisions of FDA reform legislation should ease the pressure to make stricter PMA filing decisions and quicker final actions that the agency had feared it would face under earlier versions of the bill.

Latest Headlines
See All
UsernamePublicRestriction

Register

MT009118

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