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.

 

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Key Resources

• Guidance for Industry: Product Development Under the Animal Rule
• Expanded Access to Experimental Biologics
• 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 Tissues and Advanced Therapies
• Preparation of Investigational New Drug Products (Human and Animal)
• 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

Resources for You

• Consumers (Biologics)
• Healthcare Providers (Biologics)
• Industry (Biologics)
• About the Center for Biologics Evaluation and Research (CBER)

Recalls & Alerts

• Recalls (Biologics)
• CBER-Regulated Products: Shortages and Discontinuations
• Report a Problem to the Center for Biologics Evaluation & Research

Approvals & Clearances

• Biologics Products & Establishments