Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Plan B Delay Draws Criticism From Congress, Academia, FDA Official

Executive Summary

FDA's handling of Barr's application to switch Plan B over the counter could elicit heightened external scrutiny of the agency's ability to make drug approval decisions based solely on science and public health

You may also be interested in...



Plan C? The Plan B Decision and Calls for a Third Class of Drugs

HHS Secretary Sebelius’ decision to overturn FDA’s approval of Plan B for widespread over-the-counter use was disappointing to many drug reviewers inside the agency. But FDA’s Office of New Drugs Director John Jenkins says the move should be used to reopen the debate over whether to create a third class of drugs. And Plan B, he says, might be a perfect place to start.

Plan C? The Plan B Decision and Calls for a Third Class of Drugs

HHS Secretary Sebelius’ decision to overturn FDA’s approval of Plan B for widespread over-the-counter use was disappointing to many drug reviewers inside the agency. But FDA’s Office of New Drugs Director John Jenkins says the move should be used to reopen the debate over whether to create a third class of drugs. And Plan B, he says, might be a perfect place to start.

Galson Backed Initial Plan B Denial In Fear His Job Was In Jeopardy – Jenkins

Center for Drug Evaluation & Research Director Steven Galson initially signed off on the "not approvable" letter for Barr's emergency contraceptive Plan B OTC switch in fear that he would lose his job, according to testimony by senior CDER officials

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS046286

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