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Info Collection on Expanded Access Form

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Federal Register notice: FDA sends to OMB an information collection revision entitled Expanded Access to Investigational Drugs for...

CGMP Violations in Premier Nutra Pharma Inspection

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FDA warns Carlsbad, CA-based Premier Nutra Pharma about CGMP violations in its work as a contract drug manufacturer.

Court Backs FDA in Somatuline Depot Case

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The DC federal court says FDA is correctly regulating Ipsen Biopharmaceuticals Somatuline Depot as a drug rather than as a biologi...

FDA Clears Cumulus EEG Headset

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FDA clears a Cumulus Neuroscience 510(k) for its dry-sensor Cumulus EEG headset and its use for the remote acquisition, display, a...

Genentech Vabysmo sBLA for Macular Edema

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FDA accepts for review a Genentech supplemental BLA for Vabysmo (faricimab-svoa) for treating macular edema following retinal vein...

Acrivon Gets 2 Fast Track Designations for Prexasertib

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FDA grants Acrivon Therapeutics two fast track designations for developing ACR-368 (prexasertib) in platinum-resistant ovarian can...

AI/ML Predetermined Change Control Plan Guidance

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Two Hyman, Phelps & McNamara attorneys and a medical device regulation expert analyze a recent FDA draft guidance on artificial in...

FDA OKs Expanded Farxiga Indication

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FDA approves AstraZenecas Farxiga to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart ...

Cue Health Files De Novo App for RSV Test

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Cue Health files a de novo submission seeking permission to market its Cue RSV Molecular Test for at-home and point-of-care use.

Partial Hold Lifted on Ewing Sarcoma Drug

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FDA removes a partial clinical hold against Salarius Pharmaceuticals and its Phase 1/2 clinical trial evaluating seclidemstat in p...