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

The Data Everybody's Talking About: Proof FDA is More Conservative?

This article was originally published in RPM Report

Executive Summary

Approval letters are down, "approvable" and "non-approvable" letters are up. "Black box" warnings have seen a four-fold increase over the last five years. Biopharma executives are now drawing their own conclusions about the state of FDA regulation-based on the numbers.

You may also be interested in...



Treat and Trade: The New Priority Review Voucher Market

Starting in September, pharmaceutical companies will have the opportunity to buy the right to a faster FDA review on the open market. If it works, the priority review voucher program could revolutionize development of drugs for neglected diseases, while increasing the value of more traditional commercial products in the US.

FDAAA Pays Off: Drug Safety Controls Bring Immediate Returns to Sponsors

Companies as diverse as CV Therapeutics, UCB, GSK, Pozen and Biovail are all smiles about becoming unwitting guinea pigs in the new era of drug safety. None could have expected to be pioneers in facing new post-marketing burdens-but all are thrilled that their products were approved at all. And most have seen an immediate payback for their investors.

FDAAA Pays Off: Drug Safety Controls Bring Immediate Returns to Sponsors

Companies as diverse as CV Therapeutics, UCB, GSK, Pozen and Biovail are all smiles about becoming unwitting guinea pigs in the new era of drug safety. None could have expected to be pioneers in facing new post-marketing burdens-but all are thrilled that their products were approved at all. And most have seen an immediate payback for their investors.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS080192

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