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


BIO, PhRMA Oppose Granting FDA Authority To Mandate Postmarket Studies

Executive Summary

The Pharmaceutical Research & Manufacturers of America and the Biotechnology Industry Organization oppose granting FDA the power to require postmarketing studies

You may also be interested in...

PDUFA IV Negotiations Underway With FDA, Industry Working In Harmony

PhRMA will pursue earlier postmarketing commitment negotiations with FDA as part of a limited industry agenda for the third reauthorization of the Prescription Drug User Fee Act

PDUFA Provides Opportunity For Conditional Approvals, Consumer Groups Say

Consumer groups are advocating the creation of a "conditional" approval authority for FDA through the reauthorization of the Prescription Drug User Fee Act

Drugs Should Get Longer Patents In Exchange For More Safety Data – Wood

Offering extended exclusivity, in advance, for drugs that address an unmet medical need could bring a necessary boost to research and development efforts, Vanderbilt University's Alastair Wood said




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