Frequently Asked Questions on Drug Development and Investigational New Drug Applications - Press ctrl & Click on

Written on 2:05 AM by drabhishekn

Investigational New Drug Process

• An Introduction
• Definitions
• Types of INDs
• Phases of an Investigation

Investigational New Drug Application

• What are the FDA requirements for pre-clinical studies?
• What is an Investigational New Drug Application?
• Do I need to submit an Investigational New Drug Application?
• Where do I get the necessary updated forms?
• Are there instructions to help you fill out the forms?
• When will I be assigned an IND number?
• When can I start clinical trials?
• Do I need to fill out a Statement of Investigator Form 1572?
• What is an Institutional Review Board?
• Does a physician, in private practice, conducting research with an FDA regulated product, need to obtain IRB approval?
• Does a clinical investigation involving a marketed product require IRB review and approval?
• Do I need informed consent?
• What are the specific divisions and contacts in CDER who can answer my questions?

 

Posted in FAQs

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