Investigational New Drug (IND) Application

The IND application contains sufficient information to allow an unapproved drug or biologic to be safely administered to humans. It must contain information in the following three broad areas: Animal Pharmacology and Toxicology Studies, Manufacturing Information and, Clinical Protocols and Investigator Information.

The three types of INDs include:

• Investigator IND – FDA to authorize clinical evaluation of the safety and efficacy of an unapproved drug for a particular condition
• Emergency Use IND - FDA to authorize use of an experimental drug in an emergency situation that does not allow time for submission of an IND
• Treatment IND – FDA to authorize the use of experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions while the final clinical work is conducted and the FDA review takes place

Resources for IND

The following materials reflect resources designed to assist sponsors in the IND process; they include references to assistance programs, hyperlinked guidance documents, CFR regulations and additional relevant FDA provided topic links.

Guidance Documents for INDs

• Current Good Manufacturing Practice for Phase 1 Investigational Drugs http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070273.pdf
• Guidance for Industry: Exploratory IND Studies http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm078933.pdf
• Guidance for Industry Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm074980.pdf
• Q&A – Content and Format of IND’s for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm078928.pdf This guidance is intended to clarify when sponsors should submit final, quality-assured toxicology reports and/or update the Agency on any changes in findings since submission of non-quality-assured reports or reports based on non-quality-assured data. (Issued 10/00).
• Bioavailability and Bioequivalence Studies for Orally Administered Drug Products – General Considerations http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070124.pdf This guidance should be useful for applicants planning to conduct bioavailability (BA) and bioequivalence (BE) studies during the IND period for an NDA, BE studies intended for submission in an ANDA, and BE studies conducted in the post-approval period for certain changes in both NDAs and ANDAs.
• IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer. (1/2004)

Pre-IND Consultation Program

• CDER offers a Pre-Investigational New Drug Application (IND) Consultation Program to foster early communications between sponsors and new drug review divisions in order to provide guidance on the data necessary to warrant IND submission. The review divisions are organized generally along therapeutic class and can each be contacted using the designated Pre-IND Consultation List: (http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM105981.pdf)

Additional IND Resources

The CDER provides additional resources into the IND application process, at “IND Application Process”, http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/default.htm

CDER IND Review Process

The following graphic depicts the application process of an IND. At the cited source, the noted steps in the process are hyperlinked to additional information. The source provides guidance to applicants planning to file new drug applications (NDAs), biologics license applications (BLAs), or applications for supplemental indications on the evidence to be provided to demonstrate effectiveness. CDER will make a decision on a complete IND within 120 days of receipt.

Research by Theresa Pipher