Pink Sheet is part of the Business Intelligence Division 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

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

First Biosimilar Neulasta In Final Stages Of EMA Review Process

A biosimilar version of Amgen’s Neulasta has yet to be approved in the EU but one such product is in the later stages of review at the European Medicines Agency.

Biosimilars Advisory Committees

Liposomal Drugs Should Not Be Compounded – Until Technology Catches Up

US FDA’s Pharmacy Compounding Advisory Committee agrees with AbbVie that liposomal drugs and products using hot melt extrusion should be listed as prohibited from compounding – but the panel also hopes to see technology advance to change that conclusion.

Advisory Committees Manufacturing

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

Bladder Pain, Interstitial Cystitis And The Move Toward Patient-Focused Drug Development

Patients with the conditions experience the same symptoms, US FDA advisory committee concludes. Industry sponsors had advocated for combined trials, but panel did not agree with firms' recommendations on study duration and outcome measures.

Advisory Committees Clinical Trials

US FDA Weighs Whether Interstitial Cystitis Should Be Studied Separately From Bladder Pain

Advisory committee to vote on whether patients with interstitial cystitis, marked by Hunner's lesions, should be studied separately from the broader, more heterogeneous category of patients with bladder pain syndrome; recommendations could impact Aquinox and Urigen, which have drugs for IC/BPS in clinical development.

Advisory Committees Clinical Trials
See All
UsernamePublicRestriction

Register