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Hospira Recall Over Glass Particulates

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Pfizers Hospira drug unit recalls several drug lots of 4.2% sodium bicarbonate injection, 1% lidocaine HCl injection, and 2% lidoc...

FDA Allows Reformulated Novavax Vaccine

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FDA amends the emergency use authorization of Novavaxs Covid-19 vaccine adjuvanted, for use in individuals 12 years of age and old...

Galderma Sent Complete Response Letter

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FDA sends Galderma a complete response letter on its BLA for relabotulinumtoxinA (QM-1114), indicated for treating frown lines and...

Guide on 510(k) eSubmission Template

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FDA releases a final guidance entitled Electronic Submission Template for Medical Device 510(k) Submissions.

Inspection Derails Lilly Eczema BLA

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FDA sends Eli Lilly a complete response letter due to inspection problems impacting its BLA for lebrikizumab, indicated for treati...

Pilot on ANDA Model-Integrated Evidence

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CDERs Office of Generic Drugs launches a new pilot program to offer meeting opportunities to generic drug applicants who intend to...

Case Study in Corruption: Jeff Shurens CDRH

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FDA Webview editor Jim Dickinson discovers high-level corruption equivalent to the 1989 Generic Drug Scandal in Jeff Shurens CDRH,...

Novo Nordisks Rivfloza OKd for Rare Disease

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FDA approves a Novo Nordisk NDA for Rivfloza (nedosiran) injection, a once-monthly subcutaneous ribonucleic acid interference ther...

Guide on Drug Dose Banding Lableing

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Federal Register notice: FDA makes available a final guidance entitled Human Prescription Drug and Biological Products Labeling f...

FDA Clears AI Heart Failure Detector

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FDA clears an Anumana 510(k) clearance for ECG-AI LEF, an artificial intelligence-powered medical device to detect low ejection fr...