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Medical Device Seminar Offers Diverse Best Practices from FDA, Hospital Buyers and Industry Experts
Individuals and firms seeking best practices for bringing new medical technologies to market will benefit from a one-day seminar offered by the Beaumo...

FDA Approves 2008-2009 Flu Vaccines
The U.S. Food and Drug Administration (FDA) today announced that it has approved this year's seasonal influenza vaccines that include new strains of t...

FDA Extends Review Timeline for Ustekinumab Biologic License Application Three Months
Centocor announced that the U.S. Food and Drug Administration (FDA) has extended the review timeline for the Biologic License Application for ustekinu...

FDA Approves Sorin Group's First U.S. Implant of the World's Smallest Implantable Dual Chamber Pacemaker
The Sorin Group announced the U.S. Food and Drug Administration's (FDA) approval to market the REPLY family of dual and single chamber pacemakers.The ...

FDA Accepts Streamlined Phase 3 Development Plan for Q8003IR 'Dual Opioid' Pain Therapy
QRxPharma Limited, a clinical-stage specialty pharmaceutical company focused on the development and commercialization of therapies for pain and centra...

FDA Clears Sale and Marketing of Bovie Medical Corporation's MEG Laparoscopic Line
Bovie Medical Corporation, a manufacturer and marketer of electrosurgical products, announced that the Food & Drug Administration has cleared its Modu...

FDA Clears Test that Helps Identify Type of Cancer in Tumor Sample
The U.S. Food and Drug Administration has cleared for marketing a test that can help health care professionals determine what type of cancer cells are...

FDA Reviewing Biomoda Submission for Cancer Screening Study
Biomoda, a development stage medical diagnostics company, submitted to the FDA a pre-IDE (Investigational Device Exemption) protocol for a clinical st...

FDA Advises Against Consumption of American Lobster (Maine Lobster) Tomalley
The U.S. Food and Drug Administration today warned consumers to avoid eating tomalley in American Lobster (Maine Lobster), regardless of where the lob...

IRIS to Proceed with New FDA 510(k) Pre-Market Notification for NADiA PSA After FDA Discussions
IRIS International, after extensive consultation with the US Food and Drug Administration (FDA), intends to resubmit its 510(k) for its NADiA™ PSA (Pr...

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