Investigational Drug and Biologics Research

To request any of the templates below, please email our research navigators at ICTR_Navigators@jhmi.edu.


Guidance and Templates
FDA Formal Meeting Requests

  • FDA Formal Meeting Request Guidance and Template
  • FDA Formal Meeting Request Blank Template

IND Exemption Request

  • IND Exemption Request Guidance

IND Application

  • IND Application Guidance and Template for Drug Products
  • IND Application Blank Template for Drug Products
  • IND Application Guidance Template for Biologic (Somatic Cell Therapy) Products
  • IND Application Blank Template for Biologic (Somatic Cell Therapy) Products

Letters of Authorization/Right of Reference for INDs

  • Letter of Authorization Guidance and Template for Drug Master Files
  • Letter of Authorization Guidance and Template for Investigational New Drug and Biologic Products

IND Annual Reports

  • IND Annual Progress Report Guidance and Template Drug Products
  • IND Annual Progress Report Blank Template Drug Products

IND Protocol Amendments

  • IND Protocol Amendments Guidance and Template for Drug Products
  • IND Protocol Amendments Blank Template for Drug Products

IND Information Amendments

  • IND Information Amendments Guidance and Template for Drug Products

Protocol Development Resources

  • Protocol Development Guidance for Clinical Investigations Using FDA Regulated Drug Products

FDA Audit Preparation Resource

  • FDA Audit Preparation Resource and Checklist

Compassionate Use-Individual IND Application

  • Compassionate Use-Individual IND (Expanded Access) Guidance and Template

Withdrawal/Closure of IND Application

  • Withdrawal of IND Application for an Investigational Drug

Inquiries and Requests for Support

Please submit anĀ ICTR Connection Request.