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FDA okeys Migenix's Enrollment in Phase III Clinical Trial of Omigard for Preventing Catheter-Related Infections
Cadence Pharmaceuticals, announced that the U.S. Food and Drug Administration (FDA) has agreed with the company's plan to increase the number of pati...

Stryker to Market FDA Approved Hip Resurfacing System In Third Quarter of 2007
Stryker Corporation announced that it will begin marketing Corin Group PLC's Cormet Hip Resurfacing System as early as the third quarter of this year....

Restricted Use of Zelnorm for Qualifying Patients Okey, Says FDA
The U.S. Food and Drug Administration announced that it is permitting the restricted use of Zelnorm (tegaserod maleate) under a treatment investigatio...

FDA Clears Lutronic's MOSAIC Fractional Laser System
Lutronic USA announced that its MOSAIC fractional laser system has received US FDA 510 clearance for dermatological procedures requiring the coagulati...

Scientific, Regulatory Challenges Addressed in FDA Nanotechnology Report
The U.S. Food and Drug Administration (FDA)’s Nanotechnology Task Force today released a report that recommends the agency consider developing guidanc...

FDA to Review QLT's Aczone Labeling Supplement for Removal of Blood Screening Requirement
QLT announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review QLT USA, Inc.'s labeling supplement (sNDA) for Aczon...

FDA clears NUCRYST Pharmaceuticals' Antimicrobial Barrier Topical Cream
NUCRYST Pharmaceuticals announced that the US Food & Drug Administration (FDA) has granted 510(k) clearance for a prescription topical cream containin...

NACS Urges Congress to Reconsider FDA's Retail Tobacco-Regulating Ability
Following a July 17 hearing, in which members of the House Energy and Commerce Committee determined that the U.S. Food and Drug Administration was ill...

Optical Image Technology And DBSi Announce Srategic Partnership
Optical Image Technology, creator of DocFinity workflow and document management software, announced a strategic business partnership with Bethlehem, P...

FDA Funding Proposal Provides Needed Resources to Bring Medical Advances to Patients Safely and Quickly
The following statement was issued by Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood following today’s markup of the FY 200...

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