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


Celebrex information disclosure

Executive Summary

FDA must release to Public Citizen's Health Research Group the raw patient data in Searle's Celebrex advisory committee packet, following a Jan. 19 summary judgement by Washington D.C. federal court Judge James Robertson that the information is not covered by Freedom of Information Act exemptions. HRG's request for release of names of Searle's scientific investigators and titles of unpublished articles by Searle investigators submitted to FDA was denied. Public disclosure of advisory committee materials was mandated under a July settlement with HRG, though the agency may redact material it considers confidential (1"The Pink Sheet" Jan. 3, p. 21)

You may also be interested in...

Advisory Cmte. Package Redaction Could Add Two Months To Priority Review

A drug receiving six-month priority review could have its review time extended by up to two months if its sponsor requests redaction of the advisory committee package, FDA said in a draft guidance.

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

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials




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