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Align Global Gene, Cell Therapy Regulation: Marks

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CBER director Peter Marks says hed like to see aligned global regulations to boost commercialization for gene and cell therapies.

FDA Approves Abbotts Epic Max Heart Valve

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FDA approves an Abbott PMA supplement for Epic Max, a stented tissue valve to treat people with aortic regurgitation or stenosis.

FDA Converts 1 Keytruda Indication to Full Approval

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FDA converts Mercks Keytruda immunotherapy from accelerated to full approval for treating certain solid tumors

Califf Says GOP Budget Cuts Would Devastate FDA

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FDA commissioner Robert Califf tells House appropriators that reported plans on budget cuts of up to 22% being floated by Republic...

Clinical Hold Lifted on Vigil Neuros VGL101

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FDA lifts its partial clinical hold against Vigil Neuroscience and doses greater than 20 mg/kg for VGL101 in clinical trials in ce...

Panel to Vote on Non-RX Birth Control Pill

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Federal Register notice: FDA announces a 5/9 Advisory Committee meeting to discuss a non-RX birth control pill.

Advisory Committee on Epinephrine Nasal Spray

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Federal Register notice: FDA announces a 5/11 Pulmonary-Allergy Drugs Advisory Committee meeting to discuss an ARS Pharmaceuticals...

Device Cybersecurity Enforcement Discretion

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An FDA guidance says the agency will start to refuse to accept cyber device premarket submissions that dont contain required cyber...

Objectionable Conditions in Med School Pediatric Trials

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FDA warns Washington University pediatrics researcher Robert Hayashi about objectionable conditions in his conduct of two clinical...

AI/ML Proliferation Leading to Many Issues: Attorney

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Gardner Law attorney Jesse Atkins suggests ways for medical device developers and manufacturers to keep up with rapidly changing F...