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

UsernamePublicRestriction

PDUFA VII Negotiations Completed, Commitment Letter Ratification Ongoing

Executive Summary

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

You may also be interested in...



Generic Drug Pilot On Model-Informed Evidence Aims To Boost Review Efficiency

US FDA officials, hoping to kick start participation in the pilot, argue modeling decisions made early in development can help streamline the ANDA review later.

Generic Drug Pilot On Model-Informed Evidence Aims To Boost Review Efficiency

US FDA officials, hoping to kick start participation in the pilot, argue modeling decisions made early in development can help streamline the ANDA review later.

New Name, Old Problems: US FDA’s Cell And Gene Therapy Office Still Facing Growth Challenges

The group will be called the Office of Therapeutic Products, but needs more people to handle its increasing workload.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS144034

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