1. A priority review is the most expeditious form of product approval by the FDA, which usually is granted only to the most critically important new drugs. 2. Currently, drug reviews are to be completed within a year, and high priority drug reviews to be completed within six months. 3. Drugs accepted for priority review usually take six months to approve. 4. Regulatory changes giving priority review to drugs developed for life-threatening diseases with no good available treatments has also helped move drugs more quickly through the pipeline. 5. Texas Biotechnology Corp. said its anticoagulant drug, Novastan, will be considered by U.S. regulators under a priority review. 6. The agency grants priority reviews to medicines that are believed to be more effective, have fewer side effects or otherwise perform better than existing drugs. 7. The Federal Drug Administration has fast-tracked Glivec for priority review, and the drug could be approved as soon as midsummer, officials said. 8. Yet Asensio argues that the company is deliberately using the promise of a priority review to spur buying in the stock. 9. Pfizer Canada tried to get a special priority review status for its application, but Canada reserves priority reviews for drugs designed to treat life-threatening illnesses. 10. Erbitux was given a priority review at the FDA, a fast track reserved for breakthrough therapies. |
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