Scrip 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

FDA Dispute Resolution Rules May Not Supplant Informal Appeals - Morrison

Executive Summary

Industry continues to exercise informal appeals rather than official dispute resolution procedures to address disagreements with FDA, Center for Drug Evaluation & Research Ombudsman Jim Morrison said.

You may also be interested in...



FDA Must Have Compelling Reason To Deny Advisory Review Request- PhRMA

FDA must present a compelling argument for denial of a sponsor's request for an advisory committee review of an unresolved scientific dispute with the agency, the Pharmaceutical Research & Manufacturers of America said in comments on FDA's draft guidance for formal dispute resolution.

Advisory Committee Dispute Resolution Requests To Be Decided In 30 Days

Appeals for dispute resolution between a product sponsor and FDA, including requests for advisory committees to hear disputes, will be approved or denied by the agency within 30 days for user fee products, a March 19 draft guidance indicates.

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
UsernamePublicRestriction

Register

PS035041

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

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