From L-R: Prevision Policy's Kate Rawson, OCE director Rick Pazdur, Hopkins professor Caleb Alexander, CBER deputy director Celia Witten, and OND Director Peter Stein (Zachary Brennan for Endpoints News)

February 26, 2024 03:03 PM ESTUpdated 03:26 PM

Advisory committee votes aren't going away with incoming reforms, FDA officials say

Zachary Brennan

Senior Editor

WASHINGTON — Two top leaders from the FDA said changes to the agency’s advisory committee process won’t eliminate the up-or-down votes whose necessity Commissioner Rob Califf …

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Advisory committee votes aren't going away with incoming reforms, FDA officials say

Zachary Brennan

Senior Editor

Sign up to read this article for free.

Among pharma CEOs, the IRA now and the IRA later get very different reactions

Bristol Myers restarts radiopharmaceutical Phase 3 trial, but delays readout by one year

Updated: With cost-cutting underway, Bristol Myers raises guidance, touts Phase 3 win and scraps another

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European drug regulator rejects Alzheimer's drug Leqembi, citing safety concerns

Critical Junctures in Gene Therapy Clinical Material Manufacturing: Where Do I Start? And Will It Work?

Ad­vi­so­ry com­mit­tee votes aren't go­ing away with in­com­ing re­forms, FDA of­fi­cials say

Zachary Brennan

Senior Editor

Sign up to read this article for free.

Among phar­ma CEOs, the IRA now and the IRA lat­er get very dif­fer­ent re­ac­tions

Bris­tol My­ers restarts ra­dio­phar­ma­ceu­ti­cal Phase 3 tri­al, but de­lays read­out by one year

Up­dat­ed: With cost-cut­ting un­der­way, Bris­tol My­ers rais­es guid­ance, touts Phase 3 win and scraps an­oth­er

An­drew Left, short sell­er who cam­paigned against Valeant, is ac­cused of fraud by SEC

Eu­ro­pean drug reg­u­la­tor re­jects Alzheimer's drug Leqem­bi, cit­ing safe­ty con­cerns

Crit­i­cal Junc­tures in Gene Ther­a­py Clin­i­cal Ma­te­r­i­al Man­u­fac­tur­ing: Where Do I Start? And Will It Work?

Advisory committee votes aren't going away with incoming reforms, FDA officials say

Among pharma CEOs, the IRA now and the IRA later get very different reactions

Bristol Myers restarts radiopharmaceutical Phase 3 trial, but delays readout by one year

Updated: With cost-cutting underway, Bristol Myers raises guidance, touts Phase 3 win and scraps another

Andrew Left, short seller who campaigned against Valeant, is accused of fraud by SEC

European drug regulator rejects Alzheimer's drug Leqembi, citing safety concerns

Critical Junctures in Gene Therapy Clinical Material Manufacturing: Where Do I Start? And Will It Work?