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Link: https://pharmdevgroup.com/investigational-new-drug-application-indspecial-protocol-assessment/

Investigational New Drug Application - Special Protocol Assessment

First, PDG will help you determine if an IND is required. FDA Guidance notes that there are times when it may not be clear if use of an FDA-regulated product might trigger an IND filing. However, FDA does not charge sponsors for Pre-IND meetings.

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Found: 07.12.2021

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