11. Howe, explaining this provision, said that purchased-power contracts and construction projects that won agency approval years ago would likely qualify for cost recovery. 12. In a voice vote, the FDA panel decided against recommending agency approval of the drug, only the second drug available to treat the debilitating disease. 13. Manufacturers have long argued that the agency delays approval simply through what the industry terms to be irrelevant testing. 14. Medtronic Inc. on Friday will ask a Food and Drug Administration advisory panel to recommend agency approval of its deep brain stimulation device to treat tremors. 15. Once a drug has agency approval to be on the market for one use, doctors can legally prescribe it for any other use. 16. The company must also get agency approval for any significant changes in its business plan. 17. The FDA panel voted to recommend agency approval of the system. 18. The FDA panel voted unanimously to recommend agency approval of the drug for use as an add-on to existing drug combinations used to prevent organ rejection. 19. The FDA will also allow such products as syringes and surgical lasers to go to market without agency approval. 20. The measures will add FDA staff and spell out procedures for agency approval of drugs and devices. |