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Draft Guide on Postmarketing Studies/Trials

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Postmarketing Studies and Clinical Trials Implementation o...

Device Recognized Standards List Modified

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Federal Register notice: FDA makes available its listing of Modifications to the List of Recognized Standards, Recognition List Nu...

Draft Guide on Breast Implant Labeling

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Federal Register notice: FDA makes available a draft guidance entitled Breast Implants Certain Labeling Recommendations to Improv...

Publicly Supported Drug Research Plays Valuable Role: Study

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Harvard Medical School researchers say publicly supported research helped at least 25% of all drugs approved by FDA between 2008 a...

Sharpless Credits FDA 2019 Opioid Actions

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FDA acting commissioner Ned Sharpless reviews agency steps in 2019 to combat the opioid crisis by implementing the SUPPORT Act.

FDA Releases New Ranitidine Contamination Test

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FDA releases a second method for evaluating presence of NDMA in ranitidine drug products.

FDA Cracks Down on Homeopathic Drugs

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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...