The process of obtaining IND approval involves several key steps:
1. Preclinical Testing: Before an IND can be tested in humans, it must undergo rigorous preclinical testing in the laboratory and in animal models to assess its safety and biological activity. 2. IND Application: Researchers must submit an IND application to the FDA, including data from preclinical studies, manufacturing information, and the proposed clinical trial protocol. 3. FDA Review: The FDA reviews the IND application to ensure that the proposed studies do not pose unreasonable risks to participants. The review process typically takes 30 days. 4. Clinical Trials: If the IND application is approved, the drug can proceed to clinical trials, which are conducted in phases to evaluate its safety, dosage, and efficacy.
