The U.S. Food and Drug Administration (FDA) announced today that it is reopening, for 60 days, the comment period for specific portions of its final guidance entitled “Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND,” which was announced in the Sept. 10, 2013 Federal Register. The comment period is reopening only for subsections of the final guidance that address the applicability of the IND regulations to clinical research studies involving cosmetics and foods (including dietary supplements).
The Agency is reopening the comment period in response to requests that it provide an additional opportunity to submit comments on these portions of the guidance. The guidance is intended to assist clinical investigators, sponsors, sponsor-investigators, and institutional review boards in determining whether human research studies must be conducted under an IND. The guidance describes the basic criteria for determining when an IND is required, describes specific situations in which an IND is not required, and addresses a range of issues that, in FDA's experience, have been the source of confusion or misperceptions about the application of the IND regulations.
Comments may be submitted online at Regulations.gov (use Docket No. FDA-2010-D-0503) or in writing. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For additional information, see the following:
- Federal Register Notice for the Reopening of the Comment Period (to be published tomorrow, Feb. 6)
- Investigational New Drug Applications (INDs) —Determining Whether Human Research Studies Can Be Conducted Without an IND