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DuPuy Marketing Unpproved Devices: CDRH

[ Price : $8.95]

A CDRH Warning Letter says DuPuy Orthopedics is marketing two devices without appropriate agency approvals.

FDA NJ District, SoCRA Plan Clinical Trials Workshop

[ Price : $8.95]

Federal Register Notice: FDA New Jersey District Office and the Society of Clinical Research Associates will hold a public worksho...

Workshop on Devices and Nanotechnology

[ Price : $8.95]

Federal Register Notice: FDA plans a public workshop 9/23 on manufacturing, characterization, and biocompatibility for medical dev...

FDA, PDA Hold Conference on Emerging Cultures for Medical Products

[ Price : $8.95]

Federal Register Notice: FDA and the Parenteral Drug Association will co-sponsor a public conference 9/13-15 on challenges facing ...

FDA Awards Orphan Grant for Graft-versus-Host-Disease

[ Price : $8.95]

FDAs Office of Orphan Products Development awards Soligenix, Inc. a $1.2 million clinical research grant to aid a Phase 3 trial of...

FDA Wont Permit Ceplene NDA Filing

[ Price : $8.95]

FDA refuses to accept for filing an EpiCept NDA for Ceplene to be used with interleukin-2 in patients with acute myeloid leukemia.

FDA Clears Canon Digital Radiography System

[ Price : $8.95]

FDA clears a Canon 510(k) for its CXDI-70C Wireless Digital Radiography System.

FDA Transcript for Brilinta Panel Meeting

[ Price : $8.95]

FDA posts a transcript of its 7/28 Cardiovascular and Renal Drugs Advisory Committee meeting involving a panel vote to recommend a...

Appeals Court Nixes Pre-approval Preemption in Redux Case

[ Price : $8.95]

The 6th Circuit Court of Appeals says a district court erred in ruling that FDAs approval of Redux for marketing preempts state cl...

MLV Gene Sequences Found in CFS Patients

[ Price : $8.95]

CBER says its researchers have found a strong association between murine leukemia viruses related gene sequences and chronic fatig...