Regulatory Science Symposium: Bringing Drugs and Biologics to Market - Session 2: "IND Submission Process"

Competencies: Pre-Marketing Requirements, Investigational New Drug (IND) Application, Regulatory Science, Clinical Research and Regulations, Clinical Trials, Regulatory and Quality Sciences, Clinical Trial Quality

Course Syllabus/Topics

1. IND (Investigational New Drug Application)
   1. Claimed Investigational exemption for a new drug
   2. Importance of INDs for unapproved products and studies involving new methods or patient groups, or approved products under new conditions
2. IND Requirements
   1. Can be waived for bioavailability/bioequivalence studies for generic drugs
3. Types of INDs
   1. Commercial IND
   2. Non-standard IND
      1. Exploratory IND
      2. Research/sponsor-investigator IND
      3. Expanded Access IND
4. Four Categories for expanded access use
5. IND components
1. Common Technical Document (CTD)
2. CTD format was developed by the International Council for Harmonisation (ICH) to standardize the format for marketing applications globally
3. Module mapping in the CTD
6. Commercial IND Implementation
7. Research IND Implementation
8. FDA Guidance on eSubmissions
9. IND Requirements
   1. Umbrella application in the US, allows multiple protocols to be submitted under one IND.
10. IND US/Regional Information
    1. Requirements in Module 1
       1. Item 1: Form FDA 1571
          1. Make sure you are using the most current version
          2. The pdf fillable form must be used
       2. Item 2: Table of contents
       3. Item 3: Introduction
          1. Provided in initial IND and annual reports
       4. Item 4: general investigational plan
       5. Item 5: investigator’s brochure
    2. Items 3 & 9: CTD module 2 summaries
    3. Item 6: protocol(s) and investigator information
       1. Form FDA 1572
    4. Item 7: chemistry, maufacturing and controls
       1. Module 3
    5. FDA CMC Guidance for Industry
    6. Item 8: Pharmacology and Toxicology
       1. Send (Standard for Exchange of Nonclinical Data)
       2. Duration of Repeated Dose Toxicity Studies to Support Clinical Trials
    7. Item 9: Previous Human Experience
    8. Additional Items 10-12
11. IND Submissions
    1. NextGen Portal
    2. IND timeline
    3. IND Maintenance
12. IND issues/actions
    1. Clinical Hold
    2. IND Inactivation
    3. IND Withdrawal
    4. IND Termination
13. Q&A

Acknowledgements:
Accompanying text created by: Mahita Parasa, Student Worker; Karen Manrique, Program Administrator, SC CTSI (kmanriqu@usc.edu)