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CDRH Draft Guide on Device Animal Studies

[ Price : $8.95]

CDRH posts a draft guidance on General Considerations for Animal Studies for Medical Devices that is intended to assist industry i...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Auric Enterprises, Inc. dba Diack, Banyan Medical, GeoTec, Genesis Biosystems, L...

Lilly Ends Development of Cardiovascular Disease Drug

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Eli Lilly ends a Phase 3 study involving its investigational cardiovascular evacetrapib due to insufficient efficacy.

Sun Scraps Appeal of Decision to Revoke ANDA Approvals

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Parent company Sun Pharmaceutical withdraws an appeal in a lawsuit filed by Ranbaxy against FDA that challenged the agencys decisi...

QS Violations Found at GeoTec

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FDAs New England District Office warns GeoTec about Quality System regulation violations in its manufacturing of radio frequency c...

FDA Delays Review on Collegium Pain Drug

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Despite a unanimous vote by an advisory committee to recommend approval, FDA tells Collegium Pharmaceutical, Inc, that it was not...

FDA Clears Baxters Home Dialysis System

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FDA clears a Baxter International 510(k) for the home-based AMIA automated peritoneal dialysis system with the ShareSource Web-bas...

FDA Fast Track for Portola Blood Thinner

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FDA grants Portola Pharmaceuticals a fast track designation for betrixaban for extended-duration prevention of venous thromboembol...

OCI Probe Behind Indictment Against AWD Group

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A federal grand jury indicts Jorge L. Pagn Kortright and his companies AWD Group Inc. doing business as El Torito USA, Inc., Allie...

FDA Posts Qualgen Form-483 from Sept. Inspection

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FDA cites Edmond, OK-based Qualgen for not having separate or defined areas and control systems to prevent contamination or mix-up...