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FDA Approves New Indication for Hospira's Precedex (Dexmedetomidine HCL) Injection
Hospira, a global specialty pharmaceutical and medication delivery company, announced that the U.S. Food and Drug Administration (FDA) approved a new ...

Roche Receives FDA Approval for Hepatitis C Viral Load Test on Its Fully Automated Real-Time PCR Platform
Roche Molecular Diagnostics today announced that the U.S. Food & Drug Administration (FDA) has approved the COBAS(R) AmpliPrep / COBAS(R) TaqMan(R) HC...

Dune Medical Launches US FDA Cleared Clinical Trial for Use of MarginProbe in Breast Cancer Surgery
Dune Medical Devices, announced the launch of a pivotal clinical trial of the MarginProbe(TM) intraoperative, real-time, positive margin detection sys...

Law Firm Confirms Health Risks for Women Raised by New FDA Med Alert
The FDA issued a Med Alert to physicians and healthcare providers that cites serious complications from vaginal slings. This is a class of product mar...

FDA Approves Updated Labeling for Psoriasis Drug Raptiva
The U.S. Food and Drug Administration today announced labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infectio...

Sermo and FDA Collaboration Brings Real-time Physician Feedback to Medical Device Safety
Sermo released survey results of a collaboration with the Food and Drug Administration (FDA) that offers candid feedback from physicians regarding rec...

iNEMI and US FDA Plan Forum on Component Reliability for Medical Electronics
The International Electronics Manufacturing Initiative (iNEMI) is planning a medical electronics forum to discuss requirements and recommendations dev...

HHS Preparing to Open FDA Offices in China, India, Europe, and Latin America This Year
The U.S. Department of Health and Human Services will send the first U.S. Food and Drug Administration (FDA) staff to China, India, Europe, and Latin ...

FDA Grants Orphan Drug Status to Reata's RTA 402 for Treatment of Pancreatic Cancer
Reata Pharmaceuticals announced that RTA 402 has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment...

FDA Launches Food Defense Awareness Training Kit for Employees in the Food Industry
The U.S. Food and Drug Administration in collaboration with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture laun...

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