Advancing Regulatory Science

Regulatory Science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products. On February 24, 2010, FDA launched its Advancing Regulatory Science Initiative (ARS), with the announcement of an FDA-NIH collaboration to speed the translation of research into medical products and therapies. A science-based initiative that is building on the success of existing FDA programs, like the Critical Path Initiative, ARS is expanding the medical product modernization model to encompass every dimension of regulatory science.

Clinical Trials and Human Subject Protection

The Good Clinical Practice Program is the focal point within FDA for Good Clinical Practice issues arising in human research trials regulated by FDA. In relation to Good Clinical Practice, the Good Clinical Practice Program:

  • Coordinates FDA policies
  • Contributes to leadership and direction through participation in FDA’s Human Subject Protection/Bioresearch Monitoring Council
  • Coordinates FDA’s Bioresearch Monitoring program with respect to clinical trials, working together with FDA’s Office of Regulatory Affairs (ORA)
  • Contributes to international Good Clinical Practice harmonization activities
  • Plans and conducts training and outreach programs
  • Serves as a liaison with the HHS Office for Human Research Protection (OHRP) and other federal agencies and external stakeholders committed to the protection of human research participants

Read More……