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

FDA's Outlook on the Drug Approval Drought

This article was originally published in RPM Report

Executive Summary

You would have to go back a quarter century to find a year with as few new drug approvals as 2007. There may be no one more concerned with the sinking approval rate of new molecular entities than FDA's Office of New Drugs Director John Jenkins. The RPM Report asked Jenkins why the stream of NMEs coming on to the market has slowed to a trickle.

You may also be interested in...



Treat and Trade: The New Priority Review Voucher Market

This is a reprint of the feature of the same title appearing in the July 2008 issue of The RPM Report.

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.

Treat and Trade: The New Priority Review Voucher Market

This is a reprint of the feature of the same title appearing in the July 2008 issue of The RPM Report.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS080395

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