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Remote Interactive Evaluation Guidance

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FDA publishes a draft guidance describing its process for requesting and conducting voluntary remote interactive evaluations of so...

Medinol Gets OK on Latest Drug-Eluting Stent

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FDA approves Medinols EluNIR-PERL drug-eluting stent for treating coronary artery disease.

Denti.AI Dental Imaging Cleared

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FDA clears a Denti.AI 510(k) for its Denti.AI Detect, which is described as a state-of-the-art imaging solution engineered to aid ...

FDA Decision on Florida Drug Imports Delayed: Report

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Florida officials ask a federal court to give FDA a bit longer to decide whether to approve a state plan to import some drugs from...

Akebia Refiles Kidney Disease NDA

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FDA accepts for review an Akebia Therapeutics NDA resubmission for vadadustat for treating anemia due to chronic kidney disease in...

Positive Results from BioXcel Data Audit

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BioXcel Therapeutics says an independent data integrity audit of a TRANQUILITY II clinical trial site that was the subject of an F...

Califf Positive on Visit to India

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FDA commissioner Robert Califf posts a positive report on his recent visit to India and the work he says that the countrys governm...

Dermatologic Corticosteroid BE Guidance

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FDA publishes a draft guidance to assist ANDA applicants in demonstrating the bioequivalence of topical corticosteroids.

FDA Approves New Tibsovo Indication

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FDA approves a new indication for Servier Pharmaceuticals Tibsovo to treat adults with some myelodysplastic syndromes as detected ...

UCB Farchim FDA-483 Released

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FDA releases the form FDA-483 with four observations from an inspection at Switzerlands UCB Farchim drug manufacturing facility.