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

Another Reorg For US FDA Drug Office: Dispute Resolution Program Moves Out

Executive Summary

In another sign of the increasing influence of generics within FDA, CDER Director Woodcock moves the formal dispute resolution program out of the Office of New Drugs.

You may also be interested in...



Keeping Track: Xarelto Earns CV Risk Reduction Claim In Quiet Week; Spotlight On Formal Dispute Resolution

Latest drug development news and highlights from our US FDA Performance Tracker

US FDA's Rare Diseases Program Not Expected To Change With Drug Office Reorg

Reviewer expertise may be better leveraged in more focused roles, but basic tenets of rare disease program should not fundamentally change as part of proposed Office of New Drugs reorganization.

BIO Notebook Day 3: ARM Launches Foundation To Educate Public About Gene And Cell Therapies

Alliance for Regenerative Medicine initiative seeks to explain gene and cell therapy to the general public. Also, EY's Giovannetti says strategic decisions, not tax reform, should drive deal-making; FDA's Woodcock touts benefits of new drug review office overhaul; and Siga Technologies eyes priority review voucher upon approval of Tpoxx for smallpox.

Related Content

Topics

UsernamePublicRestriction

Register

PS123255

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