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Regulatory Affairs Committee

Mission Statement

Biocom’s Regulatory Affairs Committee aims at addressing regulatory and scientific issues faced by the life science community of California. The committee provides insight on legislative and regulatory proposals affecting the industry, recommends official positions, and acts as a resource for the Biocom membership.

Committee Make-Up

The Committee is open to all Biocom members (industry and providers) who work or have an interest in regulatory affairs. Breakfast meetings, featuring special programming, are held once a quarter. Committee members are strongly encouraged to attend in-person meetings.

Committee Overview

Committee members are at the forefront of FDA’s and other agencies’ activities through regular updates by Biocom staff on the latest legislative and regulatory developments.

The Committee helps review and comment on select legislative proposals, rulemaking, and guidances affecting the industry, and recommends positions to the Public Policy Oversight Committee, which is tasked with developing Biocom’s official positions. The Committee also provides feedback on Biocom events and initiatives related to regulatory activities.

Once a quarter, members meet in person and enjoy networking, exchanging best practices, and discussing matters of common interest around food and refreshments. They are also briefed on a specific regulatory matter by industry experts (members are welcome to suggest topics and present).

In the past years, committee members have engaged in a broad range of issues, including FDA funding, user fees reauthorization negotiations, legislative proposals to improve the drug and device review and approval process, FDASIA implementation, the biosimilars approval pathway, and compounding regulations, among many others.

Biocom Staff Contact:

Committee Chairs

  • Lori McDonald, Vice President Compliance, Althea
  • Scott Cunningham, Partner, Covington & Burling