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FDA Eases Pooled Serial Screening Claims for Covid Tests

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FDA eases possible pooling of some Covid test nasal specimens in serial testing programs.

Y-mAbs Submitting Omburtamab Data Sought by FDA

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Officials of Y-mAbs Therapeutics say they are collecting additional omburtamab data sought by FDA to be able to agree on a statist...

Court Hits FDA Discretion in Drug/Device Decisions

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The DC Circuit Court of Appeals affirms a lower court decision that FDA is not afforded discretion when a combination product meet...

FDA Overreacted on J&J Vaccine Pause: Ex-Official

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Pacific Research Institute senior fellow and former FDA Office of Biotechnology director Henry I. Miller says FDAs decision to rec...

Tenacore Recalls Alaris Pumps Over Bezel Posts

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Tenacore recalls Alaris Pumps it serviced because bezel repair posts may crack or separate leading to inaccurate fluid delivery.

J&J Vaccine Maker Halts Production

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Emergent BioSolutions, contract Covid-19 vaccine supplier to Johnson & Johnson, agrees to not manufacture bulk drug substances and...

FDA Hits Block Scientific Over Covid Products

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FDA sends Block Scientific a Warning Letter after reviewing its Web site and determining it is marketing Covid-19 test kits withou...

Agenus BLA for Cervical Cancer Therapy

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Agenus files a BLA seeking accelerated approval for balstilimab, an anti-PD-1 antibody for treating patients with recurrent or met...

Clinical Hold on Ovarian Cancer Cell Therapy

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FDA places a clinical hold on an Anixa Biosciences ovarian cancer chimeric antigen receptor-T cell therapy being developed in part...

Some Software Functions Exempted from Device Definition

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Federal Register final rule: FDA amends certain medical device classification regulations to exclude certain software functions fr...