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Issues in Medtronic Northridge Inspection

[ Price : $8.95]

FDA warns Medtronic about Quality System and Medical Device Reporting violations at its Northridge, CA, manufacturing facility.

Computational Modeling Credibility Guidance

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FDA issues a draft guidance on assessing the credibility of computational modeling and simulation in medical device submissions.

EUA for Mercks Molnupiravir Covid Treatment

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FDA issues an emergency use authorization for Mercks molnupiravir to treat mild-to-moderate Covid-19 in some adults.

Padagis Recalls Nitroglycerin Spray

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Padagis recalls three lots of 12 g spray bottles of nitroglycerin lingual spray labeled for Perrigo due to the potential for a def...

EUA for Pfizer Paxlovid Covid Pill

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FDA grants an emergency use authorization for Pfizers Paxlovid, the first oral treatment for some Covid-19 cases.

FDA Tentatively Approves Vasopressin ANDA

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FDA tentatively approves Amphastars vasopressin injection, a generic form of Pars Vasostrict.

FDA Accepts Amylyx Alzheimer Drug NDA

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FDA sets a 6/22 PDUFA action date for an Amylyx NDA for its Alzheimers investigational drug.

FDA Clears Bioventus Bone Scalpel

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FDA clears Bioventus neXus bone scalpel handpiece.

Benign Prostatic Hyperplasia Device Guidance

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FDA issues a guidance with recommendations on non-clinical and clinical studies for medical devices to treat benign prostatic hype...

Fast Track for Celularity CYNK-001 for AML

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FDA approves fast track designation for an acute myeloid leukemia indication for Celularitys CYNK-001 cell therapy.