Fed Regist. 1998 May 12;63(91):26066-9.
The Food and Drug Administration (FDA) is repealing its regulations governing certification of antibiotic drugs. The agency is taking this action in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDAMA repealed the statutory provision in the Federal Food, Drug, and Cosmetic Act (the act) under which the agency certified antibiotic drugs. FDAMA also made conforming amendments to the act.
美国食品药品监督管理局(FDA)正在废除其关于抗生素药物认证的规定。该机构正在根据1997年《食品药品管理现代化法案》(FDAMA)的条款采取这一行动。FDAMA废除了《联邦食品、药品和化妆品法案》(该法案)中规定该机构对抗生素药物进行认证的法定条款。FDAMA还对该法案进行了相应修订。