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

NDA/PLA REVIEWS MAY NOT BE DELAYED DUE TO GENERAL DATA INTEGRITY ISSUES UNDER PhRMA FDA REFORM PLAN; OTC OFFICE WOULD RETURN TO REVIEW ALL SWITCHES

Executive Summary

FDA's "applications integrity policy" would be overturned by a provision of the Pharmaceutical Research & Manufacturers of America FDA reform plan.

You may also be interested in...



Clarinex Approval Precedes Consent Decree, But Follows Schering GMP Work

The approval of Schering-Plough's antihistamine Clarinex reflects the company's re-qualification and re-validation of equipment in its Las Piedras, Puerto Rico manufacturing facility

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

OM017301

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