A priority review is given to a New Drug Application or Biologics License Application if the drug treats an unmet medical need. It cuts the review time under the Prescription Drug User Fee Act from 10 months down to 6 months.
Recent Mentions on Fool.com
- Great Cholesterol Drug Data From Regeneron Pharmaceuticals Inc. and Sanofi SA, but Read the Fine Pri
- 7 Things Regeneron Pharmaceuticals Inc.'s Management Wants You to Know
- $8.3 Billion Buyout: InterMune Inc. Stock Shareholders Can Breathe Easier Thanks to Roche
- Tuesday?s Top Biotech Stories: Johnson & Johnson, Roche, Novartis, Google
- This Week in Biotech: Anacor's FDA A-OK and AbbVie's Insatiable Urge to Buy Something
- Why Zogenix Inc. Stock Tumbled