part_subject: "INVESTIGATIONAL NEW DRUG APPLICATION"
subpart_code: "E"
subpart_subject: "Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses"
section_number: "312.86"
section_subject: "Focused FDA regulatory research."
cfr_reference: "21 CFR 312.86"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 300 to 499"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
---
At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical, chemical/manufacturing, and clinical phases of drug development and evaluation. When initiated, FDA will undertake such research efforts as a means for meeting a public health need in facilitating the development of therapies to treat life-threatening or severely debilitating illnesses.