View Rule
| Printer-Friendly Version Download RIN Data in XML |
| HHS/FDA | RIN: 0910-AF15 | Publication ID: Fall 2006 |
| Title: Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application | |
| Abstract: This final rule follows a proposed rule, which proposed to update the standards for the acceptance of foreign clinical studies not conducted under an investigational new drug application (IND) as support for an IND or marketing application for a drug or biological product. We proposed to replace the requirement in 21 CFR 312.120 that non-IND foreign clinical studies be conducted in accordance with ethical principles stated in the Declaration of Helsinki or with the laws and regulations of the country that is the research site, whichever provide greater protection to subjects. We would replace that with a requirement that such studies be conducted in accordance with good clinical practice (GCP), including review and approval by an independent ethics committee. The proposed GCP standard is consistent with the standard of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use for GCP and is sufficiently flexible to accommodate differences in how countries regulate the conduct of clinical research and obtain the informed consent of patients. | |
| Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
| RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
| Major: Undetermined | Unfunded Mandates: No |
| CFR Citation: 21 CFR 312.120 | |
| Legal Authority: 21 USC 355(d)(5); 21 USC 355(i); 21 USC 371(a); 42 USC 262(a)(2)(A); 42 USC 262(a)(2)(B)(i)(l) | |
|
Legal Deadline:
None |
|||||||||
Timetable:
|
| Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
| Small Entities Affected: No | Federalism: No |
| Included in the Regulatory Plan: No | |
|
Agency Contact: Brian L. Pendleton Senior Policy Advisor Department of Health and Human Services Food and Drug Administration Suite 3037 (HFD-7), Office of Policy, WO32, Room 4245, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002 Phone:301 796-4614 Fax:301 847-8616 Email: brian.pendleton@fda.hhs.gov |
|
