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.
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This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.
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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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NHS England Picks Up Glucose Monitors for Type 1 Diabetes Patients
The devices are now available on prescription for all patients that qualify through NHS’ clinical guidelines.
FDA Expands Approval of Bristol-Myers Squibb’s Empliciti
EPd is the first triplet combination approved based on a randomized clinical trial using pomalidomide and dexamethasone as comparators.
FDAnews Drug Daily Bulletin
CARDIOME/ASTELLAS: FDA SETBACK FOR HEART DRUG
June 5, 2006
