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CDRH posts a draft guidance on General Considerations for Animal Studies for Medical Devices that is intended to assist industry i...[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Auric Enterprises, Inc. dba Diack, Banyan Medical, GeoTec, Genesis Biosystems, L...[ Price : $8.95]
Eli Lilly ends a Phase 3 study involving its investigational cardiovascular evacetrapib due to insufficient efficacy.[ Price : $8.95]
Parent company Sun Pharmaceutical withdraws an appeal in a lawsuit filed by Ranbaxy against FDA that challenged the agencys decisi...[ Price : $8.95]
FDAs New England District Office warns GeoTec about Quality System regulation violations in its manufacturing of radio frequency c...[ Price : $8.95]
Despite a unanimous vote by an advisory committee to recommend approval, FDA tells Collegium Pharmaceutical, Inc, that it was not...[ Price : $8.95]
FDA clears a Baxter International 510(k) for the home-based AMIA automated peritoneal dialysis system with the ShareSource Web-bas...[ Price : $8.95]
FDA grants Portola Pharmaceuticals a fast track designation for betrixaban for extended-duration prevention of venous thromboembol...