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FDA Approves Spectrum Pharmas Rolvedon

[ Price : $8.95]

FDA approves Spectrum Pharmaceuticals Rolvedon (eflapegrastim-xnst) injection for decreasing febrile neutropenia-associated infect...

FDA Revokes 2 EUAs for Covid Tests

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Federal Register notice: FDA revokes two emergency use authorizations one issued to Becton Dickinson and the other to Talis Biome...

Draft Guide on Sodium/Potassium/Phosphorus Labeling

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Federal Register notice: FDA makes available a draft guidance entitled Quantitative Labeling of Sodium, Potassium, and Phosphorus ...

Pfizer NDA for Alopecia Drug Accepted for Review

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FDA accepts for review a Pfizer NDA for baldness drug ritlecitinib for treating adults and adolescents with alopecia areata.

Real-World Data/Evidence Submission Guidance

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Federal Register notice: FDA makes available a final guidance entitled Submitting Documents Using Real-World Data and Real-World E...

RWD, RWE Submission Guidance

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FDA publishes a final guidance on identifying real-world data and real-world evidence submitted in INDs, NDAs, and BLAs.

FDA Denies 2014 LASIK Petition

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FDA denies a petition seeking a Boxed Warning for excimer lasers used in LASIK procedures.

At-home AI Skin Cancer Screener Being Studied

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Sklip Inc. receives IRB approval to clinically test its Sklip artificial intelligence skin cancer triage system with patients in h...

Orilissa Regulatory Review Period Determined

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Neurocrine Biosciences Oril...

OTC Drug Labeling Information Collection

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Federal Register notice: FDA seeks comments on an information collection revision entitled General Drug Labeling Provisions and OT...