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Updated Safety Info on Endologix Grafts

[ Price : $8.95]

FDA updates its 12/2020 safety communication on Endologixs AFX endovascular graft systems used in treating abdominal aortic aneury...

Mentor MemoryGel Boost Breast Implant OKd

[ Price : $8.95]

FDA approves Mentors MemoryGel Boost Breast Implant for breast augmentation in women at least 22 years old, and for women of all a...

Public Hearing on Carbadox Carcinogenic Concern

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Federal Register notice: FDA announces a 3/10 virtual public hearing on scientific data and information related to the residue of ...

FDA Covid Drug Limits Criticized

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A physician and a trade association executive say FDA requirements for using Covid-19 antiviral drugs will work against people who...

FDA Clinical Hold on Denali Alzheimers Drug

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FDA puts a clinical hold on Denali Therapeutics DNL919 IND for Alzheimers.

Initial Device Safety Summaries Out

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FDA releases nine safety summaries for materials that are commonly used in implantable medical devices.

Companies Seek Expanded Sotrovimab EUA

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GlaxoSmithKline and Vir ask FDA to allow intramuscular administration of their Covid-19 monoclonal antibody treatment sotrovimab.

Clinical Trial Company Owner Pleads Guilty

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The Justice Department says Miamis Olga Torres pleaded guilty to obstructing an FDA inspection at the Florida clinical research si...

G-Tech Medical Myoelectric Measurer Cleared

[ Price : $8.95]

FDA has cleared a G-Tech Medical 510(k) for its Wireless Patch System for myoelectric activity measurement as an aid in diagnosing...

FDA Revoking 3 Covid Tests

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Federal Register notice: FDA revokes the Emergency Use Authorizations issued to Becton, Dickinson for the BioGX SARSCoV2 Reagents ...