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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...

FDA Warns Consumers about Risk of Botulism Poisoning
The U.S. Food and Drug Administration (FDA) is warning consumers not to eat 10 ounce cans of Castleberry’s Hot Dog Chili Sauce (UPC 3030000101), Auste...

FDA gets trained by SEC Associates on Key Risks and Vulnerabilities within Computer Systems Used for Human Clinical Trials
SEC Associates, provider of validation and regulatory compliance services for life sciences organizations, recently delivered a 3-day training worksho...

First gene-based test to detect the spread of breast cancer into lymph nodes approved by FDA
Veridex, a Johnson & Johnson company, has announced U.S. Food and Drug Administration (FDA) approval of the first intra-operative and gene-based test ...

FDA: No Strong Link Found Between Tomatoes And Reduced Cancer Risk
A U.S. Food and Drug Administration (FDA) review has found only limited evidence for an association between eating tomatoes and a decreased risk of ce...

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