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 accountability for review times sought in Senate GOP concept paper.

This article was originally published in The Tan Sheet

Executive Summary

FDA ACCOUNTABILITY FOR REVIEW DEADLINES IS SOUGHT in Senate Labor & Human Resources Committee Chair Nancy Kassebaum's (R-Kan.) FDA reform concept paper. If the agency "fails to meet statutory deadlines for product review," the paper states, the appropriate FDA office director would be required "within seven days of the missed deadline" to inform the product sponsor in writing: "(1) of the reasons why additional time is necessary; (2) each remaining issue relating to the application; and (3) the projected date for completion."

You may also be interested in...



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

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

Topics

UsernamePublicRestriction

Register

IV001392

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