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Investigational New Drug. Applications Prepared and Submitted by. Sponsor- Investigators. Guidance for Industry. DRAFT GUIDANCE. This guidance document ...
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What is investigational new drug applications?
Investigational new drug applications (INDs) are requests submitted to the Food and Drug Administration (FDA) to conduct clinical trials on new drugs in humans.
Who is required to file investigational new drug applications?
Sponsors or researchers who want to test new drugs in humans are required to file investigational new drug applications.
How to fill out investigational new drug applications?
Investigational new drug applications must include information on the drug's composition, manufacturing process, preclinical data, clinical trial protocols, and plans for patient safety.
What is the purpose of investigational new drug applications?
The purpose of investigational new drug applications is to obtain FDA authorization to test new drugs in humans in order to evaluate their safety and efficacy.
What information must be reported on investigational new drug applications?
Investigational new drug applications must include information on the drug's chemistry, pharmacology, toxicology, and clinical trial design.
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