Pink Sheet is part of the Business Intelligence Division 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
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.

Advertisement

Related Content

Breakthrough In Two Pages: FDA Offers Preliminary Advice
Real-World Evidence: Efficacy Assessments Await FDA Clarity, Pilot Projects
PDUFA Negotiations: Early Communications, Breakthrough Still On Docket
FDA Safety Reports: Firms Want Advance Notice Before Public Release
PDUFA VI: FDA Proposes Expanding Sentinel, Real-World Safety Data Sources
Breakthrough Requests: FDA Adds Quick Screen To Pare Workload
Can Google Enhance Drug Safety Surveillance?
‘Breakthrough’ Fee Eyed As Deterrent To Frivolous Requests
Investors Like “Breakthrough” Therapies, But Real Test Still To Come
Social Media Site Could Help FDA Track Adverse Events

Topics

Advertisement
UsernamePublicRestriction

Register

PS078126

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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