INVESTIGATIONAL NEW DRUG APPLICATION (IND)/SPECIAL PROTOCOL ASSESSMENT (SPA)

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. PDG has orchestrated early stage strategies and Pre-IND Meetings for a variety of submissions including new clinical uses of a marketed drugs (new indications), new formulations and fixed dose combination products. Visit https://pharmdevgroup.com/investigational-new-drug-application-indspecial-protocol-assessment/