Fed Regist. 1997 Jun 16;62(115):32479.
The Food and Drug Administration (FDA) is amending its investigational new drug application (IND) regulations to clarify that, within 30 days after the receipt of an IND for any clinical investigation involving an exception from informed consent, FDA will provide a written determination as to whether the investigation may begin. This action is intended to clarify a recent amendment to the IND regulations for clinical investigations involving an exception from informed consent that states that FDA will provide a written authorization within 30 days of receipt of the IND.
美国食品药品监督管理局（FDA）正在修订其研究性新药申请（IND）法规，以明确对于任何涉及免除知情同意的临床研究，在收到IND后的30天内，FDA将就是否可以开展该研究作出书面决定。此行动旨在澄清近期对涉及免除知情同意的临床研究的IND法规修订内容，该修订规定FDA将在收到IND后的30天内提供书面批准。
