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
UsernamePublicRestriction

NME Sponsors Followed PDUFA V’s “Program” To Advisory Committee Success In 2013

Executive Summary

New review model’s elements, including the mid-cycle communication and late-cycle meeting, helped make for a smoother advisory committee process for Janssen’s Olysio and Bayer’s Adempas. The sponsors and FDA review staff were able to reach agreement on labeling and other review issues in advance, narrowing the scope of matters requiring vetting by the expert panels.

You may also be interested in...



FDA Strains Under New NDA Review Model; Will Industry Want To Retain It?

Scheduling mid- and late-cycle meetings complicates reviews for FDA, but the fate of the “Program” probably depends on whether industry feels the extra two months produces better outcomes.

FDA Needs More Time To Review Sugammadex Inspection Report, Cancels Advisory Committee

Merck’s anesthesia reversal agent, which was deemed “not approvable” in 2008, faces another setback as FDA cancels its July 18 advisory committee meeting to allow more time to review clinical trial site inspection data.

Learning From Its Successes? FDA Wants Feedback On All First-Cycle Actions For Assessment Program

Interviews with all sponsors that receive a first-cycle action, approvals as well as other outcomes, under PDUFA V’s new NME and original BLA review program will help FDA assess the program’s success.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS055878

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