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NETS - IND Application

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What is an IND application and why is it important in drug development?

An investigational new drug (IND) application is an application that must be submitted to the FDA to obtain permission to begin a clinical trial. An IND application is submitted by the clinical trial sponsor and must include documentation of the pharmacology and toxicology studies demonstrating that the compound has proven safe in animal testing. It will also contain manufacturing information, clinical protocols for the proposed clinical trial, and information on the study investigators and staff. This report must be submitted to the FDA before human testing may begin.

In Europe, a clinical trial authorization (CTA) application must be submitted prior to beginning clinical trials. Applications are submitted to National Health Agencies in each country where trials will be conducted by drug sponsors or their representatives. Clinical trial sponsors must be established within the European Community, or have a legal representative who is. Like INDs, CTAs must include documentation of pharmacology and toxicology studies, manufacturing information, clinical protocols and information on study investigators and staff.

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