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PDA Comments on Remote Interactive Evaluations

[ Price : $8.95]

The Parenteral Drug Association recommends changes to an FDA guidance on remote interactive evaluations of drug manufacturing and ...

FDA Rejects Pulse Bio Expanded Use on CellFX

[ Price : $8.95]

FDA rejects a Pulse Biosciences 510(k) for an expanded indication to treat sebaceous hyperplasia with its cleared CellFX System.

Ex-FDA Orthopedic Device Reviewer Joins NDA Partners

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Former CDRH orthopedic device medical officer Stephen Weber joins consultant group NDA Partners.

Warning on Enteral Feeding Child Strangulation

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FDA warns health care providers and parents who receive enteral feeding that there is a risk of strangulation from using enteral f...

Clin-Pharm Guide on Antibody-Drug Conjugates

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Federal Register notice: FDA makes available a draft guidance entitled Clinical Pharmacology Considerations for Antibody-Drug Conj...

$5.6 Billion in FY 2021 FCA Settlements, Judgments

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The Justice Department says it collected more than $5.6 billion in settlements and judgments under the False Claims Act in FY 2021...

Gas-Controlled Tissue Expander is Class 2

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Federal Register notice: FDA classifies carbon dioxide gas-controlled tissue expanders into medical device Class 2 (special contro...

FDA Clears Ambu Single Use Gastroscope

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FDA clears an Ambu 510(k) for its Ambu aScope Gastro and Ambu aBox 2 display, the companys first sterile single-use gastroscope, w...

Panel Reviews Pfizer Covid Pediatric Vaccine

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Federal Register notice: FDA announces a 2/15 vaccines advisory committee meeting to discuss a request to amend the Emergency Use ...

Class 2 for Alternate Controller Infusion Pump

[ Price : $8.95]

Federal Register notice: FDA classifies the alternate controller enabled infusion pump into medical device Class 2 (special contro...