Pink Sheet is part of the Business Intelligence Division 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 Drug Review, Surveillance Offices Agree To Share Safety Authority

Executive Summary

FDA's drug review and drug safety offices have set aside their differences and laid out an agreement that more equally divides regulatory authority on issues related to drug safety
Advertisement

Related Content

Separate FDA Safety Office Attached To House Report, Still Faces Steep Road
CDER Reorganization Creates Drug Safety “Super-Office”; Management Support Is Goal
CDER “Equal Voice” Policy Does Not Mean Equal Weight In Decision-Making
Rx Safety: FDA Needs Deadline - Not Funding - To Improve Process, GAO Says
Drug Safety’s “Equal Voice” To Be Considered At Internal CDER Workshop
For NME Approvals, 2008 Looks A Lot Like 2007 At Mid-Year; Will Changes At FDA Turn The Tide?
FDA’s Risk/Benefit Decisions Will Be Quantified With Metric From Contractor
For NME Approvals, 2008 Looks A Lot Like 2007 At Mid-Year; Will Changes At FDA Turn The Tide?
Even the government has plumbing problems
Safety First: FDA Unveils New Postmarketing Management Process For Safety
Advertisement
UsernamePublicRestriction

Register

PS049836

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