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Cue Health EUA for At-Home Molecular Covid Test

[ Price : $8.95]

FDA issues Cue Health an emergency use authorization for its Cue Covid-19 Test for home and over the counter use.

No More Political Pressures at FDA: Woodcock

[ Price : $8.95]

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

Warning on Using Ivermectin for Covid

[ Price : $8.95]

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

Ocular Therapeutix sNDA for Dextenza

[ Price : $8.95]

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

MedAlliance Breakthrough for Drug-Eluting Catheter

[ Price : $8.95]

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

No ANDAs Allowed for Withdrawn Belviq: FDA

[ Price : $8.95]

Federal Register notice: FDA determines that Eisais Belviq and Belviq XR (lorcaserin hydrochloride) tablets were withdrawn from sa...

Device GMP Panel Non-Voting Rep Needed

[ Price : $8.95]

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

Still No FDA AI/ML Consistent Standards: Attorneys

[ Price : $8.95]

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

NJ Court Reverses Pelvic Mesh 510(k) Cases

[ Price : $8.95]

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

Drug Compounding Outsourcing Facility Info Collection

[ Price : $8.95]

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