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Novartis Seeks Accelerated OK for Nephropathy Drug

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

Graft-versus-Host Disease Guidance

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Graft-versus-Host Diseases: Developing Drugs, Biological Pr...

De Novo Device E-filing Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Electronic Submission Template for Medical Device De Novo R...

Guide on Device Antimicrobial Testing

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Federal Register notice: FDA makes available a final guidance entitled Antimicrobial Susceptibility Test (AST) System Devices Upd...

Guide on Drug Dose Banding

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FDA posts a final guidance entitled Human Prescription Drug and Biological Products Labeling for Dosing Based on Weight or Body S...

FDA Approves Biogens Actemra Biosimilar

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FDA approves a Biogen BLA for Tofidence (tocilizumab-bavi) intravenous formulation, the first biosimilar monoclonal antibody refer...