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


FDA “Program” Reviews Are Positive So Far, But Are They Sustainable?

This article was originally published in RPM Report

Executive Summary

Early feedback on FDA’s review “Program” for new drugs and biologics is cautiously optimistic. FDA is meeting user fee goals. Communication between reviewers and drug sponsors has dramatically improved. And even trickier applications have done unusually well at advisory committee meetings. But FDA’s John Jenkins acknowledges that a lack of resources is straining the system – and forcing the agency to adapt.

You may also be interested in...

The “Program” At Half-Time: Report Finds Happy Sponsors, But Tweaks Suggested

Drug sponsors are enthusiastic about FDA’s new review “Program” for novel drug and biologic applications. But they also want to see some tweaks to make the review process even more efficient – ideas that are sure to be brought to the PDUFA VI negotiating table. One trouble spot FDA says will be addressed right away: manufacturing facility inspections for Program applications.

A Peak Year For Drug Approvals, But Can R&D Keep Up With FDA?

FDA topped 40 new molecular entity approvals in 2014, leaving no doubt that the agency’s drug review group is operating at peak efficiency. But it is still far from clear that drug development is out of the doldrums.

FDA Review “Program” Tweaks May Include Smaller Mid-Cycle Meetings

Mid-cycle meetings under FDA’s review “Program” have ballooned into 30- to 40-person affairs – far larger than originally envisioned under PDUFA V – making mid-cycle calls difficult to schedule, especially for expedited products with tight review timeframes. It is one lesson learned from the Program’s first 18 months.

Related Content


Related Companies

Latest Headlines
See All



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