The FDA has refused to accept an application for a proposed treatment of atrial fibrillation. The approval of Cardiome's new treatment for atrial fibrillation is set to be delayed by almost a year after the FDA refused to file an application for the drug.
Pharmaceutical Business Review
Simplifying Global Compliance
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GMP Inspection Preparation Checklist: A Tool for Internal Auditing
This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.
Biological Risk Evaluation and Management for Medical Devices
Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
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Gramercy’s Nitinol Staple System Cleared by FDA
The device provides an array of sterile symmetric and asymmetric, barbed and smooth staples.
Stakeholders Offer Feedback on New National Drug Code Format
Among other options, the agency proposed a new, expanded 12-digit format.
FDAnews Drug Daily Bulletin
CARDIOME/ASTELLAS: FDA SETBACK FOR HEART DRUG
June 5, 2006
