An Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. Such authorization must be secured prior to interstate shipment and administration of any new drug or biological product that is not the subject of an approved New Drug Application or Biologics/Product License Application.
- Draft Guidance for Industry: Product Development Under the Animal Rule (PDF - 574KB)
Expanded Access Information on Submitting an Investigational New Drug Application Federal Register Notice: New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible; Final Rule 5/31/2002 (aka Animal Rule) Clinical Investigator Information Participation of Females in Clinical Trials and Gender Analysis of Data in Biologic Product Applications[ARCHIVED] References for the Regulatory Process for the Office of Cellular, Tissue and Gene Therapies Preparation of Investigational New Drug Products (Human and Animal)(PDF - 795KB) U.S. Food and Drug Administration Statement: The impact of February’s inclement weather on Prescription Drug User Fee Act (PDUFA) and Medical Device User Fee Act (MDUFA) deadlines
FDA Clinical Investigator Training Course Co-sponsored by FDA's Office of Critical Path Programs and the Clinical Trials Transformation Initiative (CTTI), with support from the National Institutes of Health