To request any of the templates below, please submit a DDRS service request.
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
