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

PDUFA VI: Breakthrough Issues Among FDA Priorities

This article was originally published in The Pink Sheet Daily

Executive Summary

Agency and industry also decide to drop research into using social media to enhance post-market safety monitoring.

You may also be interested in...



Breakthrough In Two Pages: FDA Offers Preliminary Advice

Agency now allows sponsors of potential breakthrough therapies to request preliminary advice, but sponsors may not necessarily want to use it.

Real-World Evidence: Efficacy Assessments Await FDA Clarity, Pilot Projects

Greater development and use of real-world evidence, such as pragmatic clinical trials and observational studies, to support regulatory decisions on drug efficacy are limited by regulatory, technical and practical hurdles, stakeholders say.

PDUFA Negotiations: Early Communications, Breakthrough Still On Docket

FDA and industry also talking about improvements to combination product review process as part of user fee program renewal.

Related Content

Topics

UsernamePublicRestriction

Register

PS078126

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