NCTR provides a resource for collaboration through consultation, training, and innovative scientific solutions in support of FDA's mission to improve public health. The unique scientific expertise of NCTR supports FDA product centers and their regulatory roles. OCS and NCTR work closely to address bioinformatic needs in CDER.
Since 2012, the Pharmaceutical Users Software Exchange (PhUSE) Computational Science Collaborations have provided a platform for academia, regulators, industry, and technology providers to address computational science needs in support of regulatory review. This collaboration has been supported by PhUSE, the Center for Drug Evaluation and Research (CDER), and the Center for Biologics Evaluation and Research (CBER), resulting in the development of resources that improve preparation and analysis of regulatory data and associated documentation.
FDA participants follow the guidelines set forth in the MAPP 4100.2: CDER Staff Participation in Public Private Partnerships and Consortia. This MAPP facilitates consistency and continuity for those engaged in Public Private Partnerships (PPPs) and consortia. The process below outlines how FDA can evaluate and incorporate deliverables into FDA Documentation in compliance with Good Guidance Practices (GGPs).
For more information contact Office of Computational Science.