Published in Oncology Business Week, March 12th, 2006
A priority designation is intended for products that address unmet medical needs. Under the Prescription Drug User Fee Act, for BLAs filed in 2005, the FDA's goal is to review and act on BLAs designated as priority review within 6 months of receipt.
The FDA has informed Merck the review goal date is June 8, 2006.
Want to see the full article?
Welcome to NewsRx!
Learn more about a six-week, no-risk free trial of Oncology Business Week