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FDA General

No More Political Pressures at FDA: Woodcock

FDA acting commissioner Janet Woodcock tells NPRs All Things Considered that the agency is now free of political pressure and making science- and data...

Human Drugs

Warning on Using Ivermectin for Covid

FDA warns against the use of ivermectin to treat Covid-19, citing safety concerns.

Human Drugs

Ocular Therapeutix sNDA for Dextenza

FDA accepts for review an Ocular Therapeutix supplemental NDA for Dextenza (dexamethasone ophthalmic insert) 0.4 mg for treating ocular itching associ...

Medical Devices

MedAlliance Breakthrough for Drug-Eluting Catheter

FDA grants MedAlliance a breakthrough designation for its Selution SLR, a sustained drug-eluting (sirolimus) catheter for treating atherosclerotic les...

Federal Register

No ANDAs Allowed for Withdrawn Belviq: FDA

Federal Register notice: FDA determines that Eisais Belviq and Belviq XR (lorcaserin hydrochloride) tablets were withdrawn from sale for reasons of sa...

Federal Register

Device GMP Panel Non-Voting Rep Needed

Federal Register notice: FDA seeks industry organizations interested in participating in the selection of a nonvoting industry representative to serve...

Medical Devices

Still No FDA AI/ML Consistent Standards: Attorneys

Morrison & Foerster attorneys say its not yet known what FDA will want from sponsors in its regulation of artificial intelligence/machine learning in ...

Medical Devices

NJ Court Reverses Pelvic Mesh 510(k) Cases

The New Jersey Superior Court says county courts should allow jurors to consider FDA 510(k) clearance in two pelvic mesh medical device cases.

Federal Register

Drug Compounding Outsourcing Facility Info Collection

Federal Register notice: FDA announces that a collection of information entitled Obtaining Information to Understand and Challenges and Opportunities ...

Human Drugs

Glass Stoppers and Vials Guidance

FDA publishes a guidance with recommendations for the reporting category and the content of post-approval changes for sterile drug glass vials and sto...