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U.S. Department of Health and Human Services


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October 29: We are developing an anti-cancer drug. We have reports and studies related to the drug. What are the steps to obtain FDA approval?

CDER Director's Mailbag

FDA’s Pre-Investigational New Drug Application Consultation Program is designed to facilitate and foster early communications between the Agency and potential sponsors of new therapeutics. Advice can be requested for issues related to data needed to support the rationale for testing a drug in humans; the design of nonclinical pharmacology, toxicology, and drug activity studies, including design and potential uses of any proposed treatment studies in animal models; data requirements for an Investigational New Drug (IND) application; initial drug development plans; and regulatory requirements for demonstrating safety and efficacy.

We encourage all potential drug sponsors or investigators to examine the information available at: Pre-IND Consultation Program and contact us as early in the drug-development process as possible so that they will have the opportunity to consider our recommendations in planning preclinical and clinical development programs.