Public Policy Newsletters
Public Policy Newsletter
This publication is your source for the latest policy news. Sign up to receive a copy of our monthly newsletter featuring the latest federal, state (California) and regional (San Diego, Los Angeles, Bay Area) affairs.
Biocom California Brings Energy & Ag Executives to Washington, D.C.
One of our signature federal events, our advocacy fly-in, returned this year with a focus on our energy and agriculture biotech sectors.
Roundtable with Troy Tazbaz
On March 9, Biocom California hosted a roundtable event with Troy Tazbaz, FDA’s new director of the Digital Health Center of Excellence (DHCoE).
Meet & Greets with Congress
Capitalizing on Congress fully reopening this year, Biocom California resumed in-person events in our nation’s capital this month and hosted two meet & greet events on February 1.
Regulatory & Reimbursement Newsletter
Biocom California’s membership consists of a robust makeup of biopharmaceutical, medical device, diagnostics, research institutions, and provider organizations. We also have a growing food and agriculture membership and newly launched committee. Stay in touch as we increase our policy focuses with our monthly Regulatory & Reimbursement newsletter.
CDRH launched a new Radiation Sterilization Master File Pilot Program
The program allows companies that terminally sterilize single-use medical devices using gamma radiation or EtO to submit a Master File when making certain sterilization changes. CDRH is currently seeking up to nine participants for the pilot program.
The Environmental Protection Agency (EPA) EtO Proposed Rules
The EPA released two proposed rules, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and National Emission Standards for Hazardous Air Pollutants (NESHAP), with provisions aimed at limiting ethylene oxide (EtO) emissions from medical device sterilizers.
Biocom California Comments on IRA Drug Price Negotiation Program
On April 14, Biocom California submitted comments on the Inflation Reduction Act Medicare Drug Price Negotiation Program initial guidance. Thank you to our members for their continued engagement and thoughtful feedback on this important topic.