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 Advisory Committees

Set Alert for FDA Advisory Committees

Latest From Advisory Committees

Cefiderocol Approval Likely After Panel Vote, But Future Still Clouded

Shionogi's cUTI drug clears US FDA advisory committee by 14-2, though a black box warning is possible after one of the clinical studies showed a potential mortality imbalance disfavoring cefiderocol in other diseases.

Advisory Committees Infectious Diseases

Possible Mortality Imbalance For Shionogi's Cefiderocol On US FDA Panel Agenda

Although cefiderocol demonstrated safety and efficacy in a pivotal trial for complicated urinary tract infections, there was a mortality imbalance between the study drug and comparator arms in a separate descriptive trial; the US FDA is unsure whether the imbalance was a "chance finding."
Advisory Committees Infectious Diseases

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review

Pink Sheet Podcast: Makena's Accelerated Approval Questions, Woodcock On Biobetters, Singulair's Safety Issues

Pink Sheet reporters discuss the upcoming Makena advisory committee meeting, Janet Woodcock's recent comments on the biosimilar market, and options for new safety communications for Singulair.

Advisory Committees Drug Safety

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review

'Dear Doctor Mom' – US FDA Urged To Find Way To Reach Pediatric Patient Parents With Safety Updates

How should FDA make sure new safety information gets widely disseminated – especially against a history of many communications that have not shown the sustained ability to reach the most active prescribers? The agency got an earful of suggestions from the most recent safety review of the asthma/allergy drug montelukast.

Drug Safety Advisory Committees
See All
UsernamePublicRestriction

Register

Advertisement