White Paper: FDA Investigational New Drug Application
Published June 2021
Abstract:
Interaction with the FDA begins at the clinical trial stage of the drug development process to obtain authorization for an investigational new drug (IND). An IND is a request to the FDA for authorization to administer an investigational drug to humans.
This white paper explores:
- Investigational New Drug Application
- IND Exemptions, Types, and Content
- Format Requirements
- Review Process and Timeline
- Meeting with FDA
- Expedited Programs and IND
- IND Application Guidance Documents
Keywords: FDA, clinical trial, IND filing, BLA, NDA, non-clinical studies, quality, GLP, eCTD, ICH, pre-IND meeting, expedited regulatory approval
Click here to view White paper: FDA Investigational New Drug Application