May 30, 2024 02:03 PM EDT

Lab group sues FDA over final rule regulating laboratory-developed tests

Lia DeGroot

The American Clinical Laboratory Association is arguing in a new lawsuit that the FDA has overstepped its authority by bringing laboratory-developed tests (LDTs) under its …

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Lab group sues FDA over final rule regulating laboratory-developed tests

Lia DeGroot

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Lab group sues FDA over fi­nal rule reg­u­lat­ing lab­o­ra­to­ry-de­vel­oped tests

Lia DeGroot

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

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

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

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?

Lab group sues FDA over final rule regulating laboratory-developed tests

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

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

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

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?