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. Moreover, PDG has had success in using existing data from both clinical and animal models to support utility in new indications.
Should the IND be required, PDG will help you every step of the way in compiling, submitting and amending your IND as well as preparing IND Annual Reports. PDG will investigate and summarize available safety information to support reasonable safety for study in humans, prepare the protocols and Investigator Brochures, and help you address and prepare for manufacturing issues including DMF Letters of Authorization, stability and GMP issues.
Special Protocol Assessment
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. FDA actually signs an agreement that if the study is conducted as specified in the SPA and the endpoints are met, the drug will be approved. Experience has taught PDG that a SPA is reassuring to investors that endpoints are appropriate for approval and that the sponsor is in serious dialogue with FDA in its development efforts.
One of PDG’s primary goals (and successes) in Pre-IND Meetings and through the compilation and submission of the IND is to provide FDA with developmental context as well as assurance that they will receive a complete and timely protocol for SPA consideration.