March 31, 2025 05:20 PM EDTUpdated 21 hours ago

Federal judge nixes FDA's lab-developed test rule, says it exceeded agency's authority

Nicole DeFeudis

Editor

The FDA overstepped its authority when it issued a rule last May to bring laboratory-developed tests under the agency’s regulation, a Texas federal court held …

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Federal judge nixes FDA's lab-developed test rule, says it exceeded agency's authority

Nicole DeFeudis

Editor

Sign up to read this article for free.

Firings sweep across FDA as former leaders lament the gutting of drug agency

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‘It’ll be a challenge’: BIO chief Crowley addresses seismic FDA overhaul

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Big ambitions at Merck and AstraZeneca — along with a few giant pitfalls — reshape top ranks of the R&D 15

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Fed­er­al judge nix­es FDA's lab-de­vel­oped test rule, says it ex­ceed­ed agen­cy's au­thor­i­ty

Nicole DeFeudis

Editor

Sign up to read this article for free.

Fir­ings sweep across FDA as for­mer lead­ers lament the gut­ting of drug agency

RFK Jr. has long crit­i­cized drug ads. He just slashed the FDA of­fice that reg­u­lates them

‘It’ll be a chal­lenge’: BIO chief Crow­ley ad­dress­es seis­mic FDA over­haul

Sanofi con­tin­ues its bet on R&D by poach­ing GSK’s head of de­vel­op­ment

Big am­bi­tions at Mer­ck and As­traZeneca — along with a few gi­ant pit­falls — re­shape top ranks of the R&D 15

End­points we­bi­nar: In­side the “One Lon­za” strat­e­gy: Re-en­gi­neer­ing the fu­ture of CD­MO

Federal judge nixes FDA's lab-developed test rule, says it exceeded agency's authority

Firings sweep across FDA as former leaders lament the gutting of drug agency

RFK Jr. has long criticized drug ads. He just slashed the FDA office that regulates them

‘It’ll be a challenge’: BIO chief Crowley addresses seismic FDA overhaul

Sanofi continues its bet on R&D by poaching GSK’s head of development

Big ambitions at Merck and AstraZeneca — along with a few giant pitfalls — reshape top ranks of the R&D 15

Endpoints webinar: Inside the “One Lonza” strategy: Re-engineering the future of CDMO