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FDA Cracks Down on Homeopathic Drugs

[ Price : $8.95]

FDA revises a guidance and withdraws a Compliance Guide to clarify its risk-based approach to regulatory enforcement of homeopathi...

Allergan sBLA Approved for Pediatric Spasticity

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FDA approves an Allergan supplemental BLA for Botox in treating pediatric patients (two to 17 years of age) with lower limb spasti...

Info Collection Extension for Social and Behavioral Research

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Federal Register notice: FDA sends to OMB an information collection extension for Data to Support Social and Behavioral Research a...

Flowonix Larger Prometra II Infusion Pump OKd

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FDA approves a Flowonix Medical PMA to market the Prometra II 40 mL Programmable Infusion Pump and its associated programmer softw...

Safety Alert on Cholesterol-lowering CholesLo

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An FDA safety alert warns that CholesLo, a product promoted and sold for lowering cholesterol on various Web sites contains an und...

Trump Poised to Nominate Hahn to FDA: Report

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The Washington Post says President Trump is ready to name MD Anderson Cancer Center chief operating officer Stephen Hahn to be FDA...

Fresenius Gets Breakthrough on Hemodialysis System

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FDA grants Fresenius Medical Care a breakthrough device designation for its new hemodialysis system that aims to prevent blood clo...

3 Observations in East Marietta FDA-483

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FDA releases the FDA-483 with three observations from an inspection at East Marietta Drug Company.

FDA Wants Breast Implant Boxed Warning

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FDA calls for a breast implant Boxed Warning and other labeling changes to help ensure that patients have information needed to ma...

Postmarketing Study and Clinical Trial Guidance

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FDA issues a draft guidance explaining its legal authority to require certain postmarketing studies and clinical trials for certai...