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
- Why a Failure By BioMarin Caused Sarepta's Shares to Spike 53% in November
- Sarepta Therapeutics: Discretion Is the Better Part of Valor
- Johnson & Johnson's Latest FDA Approval Could Spell Problems for Amgen
- Vertex Pharmaceuticals Incorporated Moved 16% Higher in October -- Here's Why
- Why Acadia Pharmaceuticals Is Up Today
- BioMarin Pharmaceutical Inc. Earnings: Pushing Toward Profitability