Fed Regist. 2006 Jan 17;71(10):2458-62.
The Food and Drug Administration (FDA) is amending its current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most investigational "Phase 1" drugs from complying with the requirements in FDA's regulations. FDA will instead exercise oversight of production of these drugs under the agency's general statutory CGMP authority and investigational new drug application (IND) authority. In addition, FDA is making available simultaneously with the publication of this direct final rule, a guidance document setting forth recommendations on approaches to CGMP compliance for the exempted Phase 1 drugs. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule, under FDA's usual procedure for notice-and-comment rulemaking, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comments and withdraws this direct final rule. The companion proposed rule and direct final rule are substantively identical. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance for industry entitled "INDs--Approaches to Complying With CGMP During Phase 1" to provide further guidance on the subject.
美国食品药品监督管理局（FDA）正在修订其现行的人用药品（包括生物制品）良好生产规范（CGMP）法规，以使大多数处于研究阶段的“1期”药物无需遵守FDA法规中的要求。相反，FDA将根据该机构的一般法定CGMP权限和研究性新药申请（IND）权限，对这些药物的生产进行监管。此外，FDA在发布本直接最终规则的同时，还提供了一份指导文件，阐述了关于豁免的1期药物CGMP合规方法的建议。在本期《联邦公报》的其他地方，FDA正在发布一份配套的拟议规则，按照FDA通常的通知和征求意见规则制定程序，以便在该机构收到任何重大负面意见并撤回本直接最终规则的情况下，提供一个将该规则最终确定的程序框架。配套拟议规则和直接最终规则在实质上是相同的。在本期《联邦公报》的其他地方，FDA宣布提供一份题为“IND——1期期间CGMP合规方法”的行业指南草案，以提供关于该主题的进一步指导。
