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Federal Register

Device Recognized Standards List Modified

Federal Register notice: FDA makes available its listing of Modifications to the List of Recognized Standards, Recognition List Number: 052.

Federal Register

Draft Guide on Breast Implant Labeling

Federal Register notice: FDA makes available a draft guidance entitled Breast Implants Certain Labeling Recommendations to Improve Patient Communicat...

Human Drugs

Publicly Supported Drug Research Plays Valuable Role: Study

Harvard Medical School researchers say publicly supported research helped at least 25% of all drugs approved by FDA between 2008 and 2017 and could be...

Human Drugs

Sharpless Credits FDA 2019 Opioid Actions

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

Human Drugs

FDA Releases New Ranitidine Contamination Test

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

Human Drugs

FDA Cracks Down on Homeopathic Drugs

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

Human Drugs

Allergan sBLA Approved for Pediatric Spasticity

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

Federal Register

Info Collection Extension for Social and Behavioral Research

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

Medical Devices

Flowonix Larger Prometra II Infusion Pump OKd

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

Human Drugs

Safety Alert on Cholesterol-lowering CholesLo

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