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Pilot on ANDA Model-Integrated Evidence

[ Price : $8.95]

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...

Novartis Seeks Accelerated OK for Nephropathy Drug

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Novartis says it will seek accelerated approval next year for its IgA nephropathy drug iptacopan after announcing positive top-lin...

Rare Disease Drug/Biologic Pilot

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Federal Register notice: FDA announces the opportunity for a limited number of development programs to participate in the Support ...

Government Shutdown Likely This Weekend

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The U.S. government and agencies like FDA headed into the weekend as the ongoing Congressional budgetary impasse was on course to ...

FDA Proposed Rule on Lab-Developed Tests

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FDA issues a proposed rule to reign in laboratory-developed tests and increase its scrutiny of them due to their growth in use and...

Physiologic Closed-Loop Control Guide

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Federal Register notice: FDA makes available a final guidance entitled Technical Considerations for Medical Devices with Physiolog...