1. -- Redefine biotechnology products as drugs, which eliminates the need for agency approval of a manufacturing plant before product testing begins. 2. A Food and Drug Administration advisory committee is considering whether to recommend agency approval of the drug. 3. A Food and Drug Administration advisory committee voted unanimously to recommend agency approval of the drug as a secondary therapy, saying it was safe and effective. 4. A Food and Drug Administration advisory panel recommended against agency approval of a new contraceptive device made by the private company Yama Inc. 5. Agency approval could come as early as next year, Crossen said. 6. Dietary supplements, which do not require agency approval, are trickier to define. 7. During the years when the Federal Communications Commission was effectively the sole regulator of radio mergers, the FCC permitted that practice while agency approval was pending. 8. Earlier today, the same panel unanimously recommended agency approval of Albunex for use in diagnosing blockages in fallopian tubes. 9. Earlier, it received agency approval to market its Benefix treatment for hemophiliacs. 10. Gilmartin said Merck still needs several city and state agency approvals before construction can begin. |