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

Advisory Panel Members Respond To Wood Editorial In NEJM On Plan B

This article was originally published in The Tan Sheet

Executive Summary

An evaluation of package information for over-the-counter levonorgestrel needs to include typical-use and not just optimal-use rates, according to a letter to the editor in the June 3 New England Journal of Medicine signed by members of FDA's Reproductive Health Drugs Advisory Committee

You may also be interested in...



Plan B OTC Submission Fails On Lack Of Data In Teens

Barr Labs will continue to work with FDA toward approval of emergency contraceptive Plan B (levonorgestrel .75 mg) for OTC use, the company said in a May 6 statement

OTC Plan B Age Limits Would Reflect Political Taint In FDA Review – Wood

FDA's review of an Rx-to-OTC switch for the Plan B emergency contraceptive should not involve consideration of age restrictions on use, according to Alastair Wood, MD, Vanderbilt University Medical Center

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

PS096896

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