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Human Drugs

Companies Using Drug Development AI: Tufts Survey

A Tufts Center for the Study of Drug Development Impact Report says drug developers are making increasing use of artificial intelligence in a variety ...

Human Drugs

Torrent Pharmaceuticals FDA-483 Out

FDA releases the FDA-483 with four observations from an inspection at Indias Torrent Pharmaceuticals.

Medical Devices

Recros Medica De Novo Submission for Nuvellus

Recros Medica files a de novo regulatory submission for the Nuvellus Focal Contouring System.

FDA General

Latest FDA Warning Letter

FDA releases its latest batch of Warning Letters that includes one medical product company Laboratoires Clarins.

Medical Devices

Rapid Medicals Coil Embolization Assist Cleared

FDA clears a Rapid Medical 510(k) for its Comaneci Temporary Coil Embolization Assist Device.

Federal Register

Pediatric Oncology Drugs Panel Meeting

Federal Register notice: FDA announces a 6/20 Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee meeting.

Human Drugs

2 FoldRx NDAs Approved for Treating Heart Disease

FDA approves Pfizer subsidiary FoldRxs NDAs for Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for treating heart disease caused by ...

Federal Register

Draft Guide on ADHD Drug Development

Federal Register notice: FDA makes available a draft guidance entitled Attention Deficit Hyperactivity Disorder (ADHD): Developing Stimulant Drugs for...

Human Drugs

Guidance on Device Q-Submission Program

FDA makes available a final guidance entitled Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.

Medical Devices

Boston Scientifics VICI Venous Stent Approved

FDA approves a Boston Scientific PMA for the VICI Venous Stent System for treating iliofemoral venous obstructive disease.