May 24, 2023 12:21 PM EDT

Generally accepted scientific knowledge: FDA explains how it applies to nonclinical data in drug apps

Zachary Brennan

Senior Editor

Following an “increasing number of questions” on the extent to which generally accepted scientific knowledge (GASK) may be relied on by the FDA as part …

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Generally accepted scientific knowledge: FDA explains how it applies to nonclinical data in drug apps

Zachary Brennan

Senior Editor

Sign up to read this article for free.

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

Gen­er­al­ly ac­cept­ed sci­en­tif­ic knowl­edge: FDA ex­plains how it ap­plies to non­clin­i­cal da­ta in drug apps

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

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

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

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?

Generally accepted scientific knowledge: FDA explains how it applies to nonclinical data in drug apps

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

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

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

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?