BIO Regulatory Affairs Steering Committee (RASC) Meeting

The BIO Regulatory Affairs Steering Committee (RASC) acts as a steering committee for all staff-level science & regulatory committees and working groups. The RASC takes the lead or makes assignments to committees and working groups on implementation of user fee agreements, including continuous engagement activities with FDA. The RASC develops and implements strategic BIO responses to scientific and regulatory issues that affect the ability of BIO's human healthcare focused companies to research and develop new therapeutics, and to bring these products to market. The RASC responds to proposed regulations and draft guidance documents as necessary and holds liaison meetings with FDA to identify and discuss regulatory best practices.

For more information and to join the Committee, please contact Surea Gainey (sgainey@bio.org).