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Draft Guidance on Kidney Disease Biomarker

[ Price : $8.95]

FDA posts a draft guidance on Qualification of Biomarker  Total Kidney Volume in Studies for Treatment of Autosomal Domina...

Court Approves Consent Decree Against Iowa Drug Firm

[ Price : $8.95]

The northern Iowa federal court approves a consent decree of permanent injunction against Iowa Select Herbs LLC, a manufacturer an...

FDA Should End Industry Devices Influence: Public Citizen

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Public Citizen urges FDA to retract a recent draft guidance on using patient preference information in evaluating high-risk medica...

Abiomed Files PMA Supplements for Other Impella Devices

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Abiomed files PMA supplements seeking to expand its Impella 2.5 PMA approval to all Impella devices (Impella 2.5, Impella CP and I...

Guidance on Intraocular Ophthalmic Device Endotoxin Testing

[ Price : $8.95]

Federal Register Notice: FDA is making available a guidance entitled Endotoxin Testing Recommendations for Single-Use Intraocular ...

Guidance on Biomarkers for Kidney Disease Treatment

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Federal Register Notice: Notice: FDA releases a draft guidance: Qualification of Biomarker Total Kidney Volume in Studies for Tre...

Guidance on Drug Development for Rare Diseases

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Federal Register Notice: FDA releases a draft guidance: Rare Diseases: Common Issues in Drug Development.

FDA Workshop on Mobile Health/Social Data Sources

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Federal Register Notice: FDA plans a public workshop 9/11 on how mobile health and social data sources may inform medical product ...

New Labeling for BMS Sprycel Adds 5 Year Data

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FDA approves an update to Bristol-Myers Squibbs Sprycel (dasatinib) product labeling to include five-year efficacy and safety data...

CDER Guidance on Botanical Drug Development

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CDER posts a draft guidance on Botanical Drug Development that discusses appropriate development plans for botanical drugs to be s...