February 12, 2021 10:50 AM EST

FDA slaps Florida's Allay Pharmaceuticals with warning letter over vague responses to drug potency issues

Conner Mitchell

Inadequate responses to findings of potency discrepancies, blending issues and out-of-specification samples during a May 2020 inspection recently landed tablet manufacturer Allay Pharmaceuticals with a …

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FDA slaps Florida's Allay Pharmaceuticals with warning letter over vague responses to drug potency issues

Conner Mitchell

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FDA slaps Flori­da's Al­lay Phar­ma­ceu­ti­cals with warn­ing let­ter over vague re­spons­es to drug po­ten­cy is­sues

Conner Mitchell

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?

FDA slaps Florida's Allay Pharmaceuticals with warning letter over vague responses to drug potency issues

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?