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Safety Alert on Cholesterol-lowering CholesLo

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

FDA Wants Breast Implant Boxed Warning

[ Price : $8.95]

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

[ Price : $8.95]

FDA issues a draft guidance explaining its legal authority to require certain postmarketing studies and clinical trials for certai...

Info Collection Extension for Device PMAs

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension entitled Premarket Approval of Medical Devices....

Info Collection Extension on Device Surveillance

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension for Postmarket Surveillance of Medical Devices 21 C...

FDA Biosimilar Testing Now Faster Than EMA

[ Price : $8.95]

Harvard researchers say biosimilars are often approved by FDA before they are approved in Europe.

BlueWillow to Test Intranasal Anthrax Vaccine

[ Price : $8.95]

FDA approves BlueWillow Biologics to conduct a Phase 1 study of its next-generation intranasal anthrax vaccine candidate BW-1010.

Public Meeting on Clinical Outcome Assessments Pilot

[ Price : $8.95]

FDA announces a 12/5 public meeting on its Standard Core Clinical Outcome Assessments and Endpoints Pilot Grant Program.