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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Kleresca Approved in EU for Dermatological Platform
The treatment does not damage the skin’s natural barriers.
Pro-Kratom Nonprofit Pushes Back on Deaths FDA Attributed to Substance
The FDA issued warning letters in May to three U.S. distributors of more than 65 kratom products for sales of unapproved new drugs claiming effectiveness in treating opioid addiction and withdrawal.
FDAnews Drug Daily Bulletin
CARDIOME/ASTELLAS: FDA SETBACK FOR HEART DRUG
June 5, 2006