Of utmost importance, PDG has extensive experience in gaining FDA agreement for consideration of Special Protocol Assessment (SPA) of trials forming the primary basis of efficacy claims in NDAs. The SPA is an agreement between the FDA and the sponsor that addresses design and analysis issues before the study begins.

Call : 08133332950
Email : info@pharmdevgroup.com
Visit : https://pharmdevgroup.com/investigational-new-drug-application-indspecial-protocol-assessment/