The Drug and Biologics Team at NDA Partners can provide assistance for small and large companies in both near-term and long-term preparation for the critically important Pre-NDA and Pre-BLA meetings with the FDA.

Effective drug and biologic development is an integrated succession of value-added technical decisions and regulatory interactions. One of the most critically important regulatory interactions is the Pre-NDA/BLA meeting, which from the sponsor's point of view, aims to affirm that adequate knowledge has been generated to support successful filing by the FDA of an NDA/BLA that leads to approval of the proposed indications. The technical goal of the Pre-NDA/BLA meeting is to gain agreement from the FDA with regard to the format and content of the NDA/BLA, as well as the handling of specific effectiveness and safety issues, and to provide an explanation of unexpected clinical and non-clinical findings.

The understanding and implementation of NDA Partners’ second, fourth, and fifth Development Principles for Optimal Product Development (“Product Readiness”, “Learning and Confirming”, and “Regulatory Collaboration”) are required to ensure a successful preNDA/BLA meeting with FDA and other regulatory agencies.

NDA Partners expert services for the Pre-NDA/BLA stage of development include:

• Design of phase 2 and phase 3 programs that will produce the knowledge that will support a FDA decision that the NDA/BLA submission is “fileable”.
• Preparation and rehearsal of the sponsor for a successful Pre-NDA/BLA Meeting with the FDA.
• Assessment of all available effectiveness and safety knowledge, and identification of the key Pre-NDA/BLA topics and issues for which a sponsor should seek FDA input.
• Assistance in the design and conduct of a sponsor’s internal Pre-NDA/BLA decision meeting.
• Creation of focused Pre-NDA/BLA questions to ensure that the FDA response will be useful and informative (rather than a sponsor receiving a“complete response” FDA NDA/BLA review that falls short of approval).
• Assistance in preparing the Pre-NDA/BLA briefing document so that it will provide focus on the key issues and include supporting data.
• Generation of potential “Best Case” and “Worst Case” Pre-NDA/BLA meeting responses from the FDA.
• Assistance in the advance preparation of informed and cogent sponsor replies to possible FDA responses to the Pre-NDA/BLA questions.
• Participation in the rehearsals for the Pre-NDA/BLA meeting.
• Attendance at the Pre-NDA/BLA meeting.
• Assistance in the Pre-NDA/BLA debrief as the “neutral third party”.
• Assistance in defining the next steps and the design of the optimal path forward.
• Assistance in anticipating and preparation for an FDA Advisory Committee meeting.