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Guide Updated on Device Development Tools

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FDA updates its final guidance entitled Qualification of Medical Device Development Tools (MDDTs).

Ex-FDA Chief Counsel Joins Berkley Research

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Former FDA chief counsel Dan Troy joins Berkeley Research Group in the firms Washington, DC office as a managing director in its ...

AstraZeneca RSV Drug Beyfortus Approved

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FDA approves an AstraZeneca BLA for Beyfortus (nirsevimab-alip) for preventing Respiratory Syncytial Virus lower respiratory tract...

FDA Announces Priority Review Voucher Issuance

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Federal Register notice: FDA announces the issuance of a priority review voucher to Sarepta Therapeutics for its recently approved...

FDA Warns About Using RoyalVibe Ultrasounds

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FDA issues a warning against using ultrasound medical devices manufactured and distributed by RoyalVibe Health, and related compan...

Lilly Alzheimers Drug Slowed Decline by 35%

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Eli Lilly reports study results showing that donanemab significantly slowed cognitive and functional decline in people with early ...

BridgeBio Plans NDA for Cardiomyopathy Drug

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BridgeBio Pharma plans to file an NDA after reporting positive results from ATTRibute-CM, a Phase 3 study of acoramidis in transth...

Nonvoting Industry Reps for CDER Panels Sought

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Federal Register notice: FDA seeks industry organizations interested in participating in the selection of nonvoting industry repre...

Participants Sought for Patient Engagement Group

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Federal Register notice: FDA and the Clinical Trials Transformation Initiative seek patient advocates interested in participating ...

Fresenius Kabi Facility Hit With FDA-483

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FDA issues Fresenius Kabis Canton, MA outsourcing facility a Form FDA-483 over GMP deviations observed during a March inspection.