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Hiers Enterprises Hit With 483 After Inspection

[ Price : $8.95]

FDA issues Hiers Enterprises (dba Northwest Compounding Pharmacy) a Form FDA-483 after inspecting the firm in 11/2021.

aTyr Pharma Gets Orphan Status on Efzofitimod

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FDA grants aTyr Pharma an orphan drug designation for efzofitimod and its use in treating systemic sclerosis.

Amneal BLA for Avastin Biosimilar Approved

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FDA approves an Amneal Pharmaceuticals BLA for bevacizumab-maly, a biosimilar referencing Genentechs Avastin.

Shelf Life Evaluation for Bamlanivimab and Etesevimab

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FDA and HHS says that the shelf-life of Eli Lillys bamlanivimab and etesevimab, for treating Covid-19, are being evaluated, and an...

FDA Clears SonoScape Video Endoscopy Device

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FDA clears a SonoScape 510(k) for its flagship video endoscopy system HD-550 for gastrointestinal diagnosis.

Info Collection on Quick Turnaround Surveys

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Federal Register notice: FDA seeks comments on an information collection extension for Generic Clearance for Quick Turnaround Test...

Guide on Bioavailability Studies for Drug Submissions

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Federal Register notice: FDA makes available a final guidance entitled Bioavailability Studies Submitted in NDAs or INDs General ...

Adagio Pauses Covid Drug EUA Submission

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Adagio Therapeutics pauses its EUA submission for adintrevimab, a Covid-19 treatment that is not effective against the BA.2 varian...

FDA Extends Review of Regeneron Regen-Cov BLA

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After submitting additional requested data, FDA extends by three months its review of a Regeneron Pharmaceuticals BLA for Regen-Co...

Draft Guide on Celiac Disease Drugs

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Federal Register notice: FDA makes available a draft guidance on developing drugs for treating Celiac Disease.