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Medical Devices

FDA Approves Expansion of USGI Weight-Loss Procedure Trial

FDA approves expanding to 35 subjects a USGI Medical pilot study of its POSE 2.0 endoscopic weight loss procedure.

Human Drugs

Harvard, DARPA Screening FDA Covid Drug Effectiveness

The International Business Times reports that Harvard University and the Defense Advanced Research Projects Agency are collaborating on a way to deter...

Human Drugs

Tazverik Approved for Follicular Lymphoma

FDA grants Epizyme accelerated approval for Tazverik (tazemetostat), an EZH2 inhibitor for certain adult patients with relapsed or refractory follicul...

Federal Register

Guide on Patient-Focused Drug Development

Federal Register notice: FDA makes available a final guidance on Patient-Focused Drug Development: Collecting Comprehensive and Representative Input....

Human Drugs

Covid Trial Statistical Considerations Guidance

FDA issues an immediately-in-effect guidance on statistical considerations for proposed changes to clinical trials that may affect the analysis or int...

Human Drugs

Establish Regulatory Pathway for CBD Supplements: Petition

The Council for Responsible Nutrition asks FDA to lay out a regulatory pathway for approval of hemp-derived cannabidiol in dietary supplements.

Federal Register

Info Collection on Outsourcing Facility Challenges

Federal Register notice: FDA seeks comments on an information collection extension for Obtaining Information to Understand Challenges and Opportunitie...

Human Drugs

Watchdog Group Wants Teva Probe Transparency

The watchdog group Accountable.US asks attorney general William Barr to be transparent about any political interference in a price-fixing investigatio...

Federal Register

Nominations for Compounding Advisory Committee

Federal Register notice: FDA requests nominations for members to serve on its Pharmacy Compounding Advisory Committee.

Medical Devices

FDA Updates Covid Screening Test Template

FDA updates Covid-19 molecular test templates to help developers get tests authorized for broad screening of asymptomatic individuals.