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


PDUFA Hearing Will Address NDA Approval Slowdown Claims

This article was originally published in The Tan Sheet

Executive Summary

Drug approval times will be one topic of interest at the House Energy & Commerce/Health Subcommittee's May 3 hearing kicking off the user fee reauthorization process, Commerce Committee Majority Counsel Brent Del Monte told the Food & Drug Law Institute conference in Washington, D.C. April 18.

You may also be interested in...

Generics study

Office of Management & Budget clears FTC request to conduct study on Hatch/Waxman's effects on competition between branded and generic drug manufacturers; OMB approval was not deemed clear-cut, since former Eli Lilly exec Mitch Daniels heads the office. FTC will issue special orders to 30 innovator companies and 70 generics firms questioning impact of Hatch/Waxman's 180-day marketing exclusivity and 30-month stay provisions on innovation; firms must reply within 60 days. Study was first proposed last fall (1"The Tan Sheet" Oct. 16, 2000, p. 13)

Supplement GMP Warning Letters Make Modest Debut In 2010

Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC

People In Brief

Perrigo promotes in pricing, planning





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