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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EU MDR Compliance: A Checklist for Meeting Manufacturing, Safety and Performance Requirements
The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
Accelerating Generic Drug Development: The FDA’s New Plan for Increasing Generic Competition
Accelerating Generic Drug Development explains the FDA’s new policy and shows how to navigate the new pathway to approval.
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Reflexion Health’s Digital Physical Therapy System Grabs FDA OK
The system keeps track of a patient’s physical therapy progress and statistics via a dashboard.
FDA Discusses Pilot Program for Single Patient INDs
A public database tied in with the program will also list information supplied by drug companies.
FDAnews Drug Daily Bulletin
CARDIOME/ASTELLAS: FDA SETBACK FOR HEART DRUG
June 5, 2006
