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

Sponsors, FDA Reviewers To Get More Flexibility Under New User Fee Program

Executive Summary

Next iteration of PDUFA will feature new communication plans that allow FDA and sponsors to drop mid-review meetings if desired.

You may also be interested in...



PDUFA VII Negotiations Completed, Commitment Letter Ratification Ongoing

The US FDA, HHS and White House, as well as industry groups, now must sign off on the document.

US FDA's Complex Trial Design Pilot Might Be Handicapped By Disclosure Requirements

FDA wants to publicize some aspects of designs accepted into pilot, which might discourage industry participation.

ANDA Pre-Submission Meetings A 'Challenge' To Integrate Into Development Timelines

US FDA officials appears worried about workload created by product development and pre-submission meetings for complex generics.

Related Content

Topics

UsernamePublicRestriction

Register

PS118786

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