The FDA’s mission to protect and promote public health requires the Agency to maintain the trust and the confidence of the American public. To meet this mission the FDA must be seen as a collaborative partner with public and private stakeholders to rise to the challenges of bridging scientific gaps.
The development path for all products under the FDA’s regulatory purview is costly and time intensive. Non-traditional business models that leverage expertise and resources from many partners must be developed to tackle scientific problems and to help the FDA make sound regulatory decisions. The high demands for safer, more effective and less costly regulated products create an imperative for strategic partnerships with stakeholders.
The FDA will need to strengthen and expand the scope of existing partnerships, develop novel business models, and become more proactive to meet the responsibilities as the gold standard for regulatory authority under the Department of Health and Human Services. The FDA must pioneer new paths to contribute to the development of innovative technologies and face new challenges.
The mission of the FDA Public-Private Partnership Program is to create, implement, and manage strategic scientific partnerships under the FDA’s public health mission. The FDA experienced staff serve as a central resource to FDA Centers and Offices and a variety of partners to join together to develop creative innovative business models and develop mechanisms for strategic collaborations.
The FDA leverages intellectual capital, infrastructure, and in-kind and financial resources to facilitate successful implementation of programs. Ultimately, the outcomes and know-how from the joint ventures help the FDA make sound regulatory decisions that better serve the stakeholders and the American public.