Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards on Investigational New Drug Applications-Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application; Reopening of the Comment Period

摘要

The Food and Drug Administration (FDA or we) is reopening the comment period for the final guidance for clinical investigators, sponsors, and institutional review boards (IRBs) entitled "Investigational New Drug Applications (INDs)--Determining whether Human Research Studies can be Conducted without an IND," published in the Federal Register of September 10, 2013 (78 FR 55262). We are reopening the comment period only with respect to those subsections of the final guidance that address the applicability of the IND regulations to clinical research studies involving cosmetics and foods (including dietary supplements).