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.

Recent News

Government Official of the Year

This year’s Government Official of the Year Award goes to Dr. Julianne McCall, Director of Precision Medicine in the Governor’s Office of Planning & Research.

State Legislative Update

The Governor took his final actions of the 2023 legislative season on October 13, marking the end of the first year of the 2023-24 legislative cycle.

A Mid-Year Update on Policies Shaping the Life Science Industry

Our Public Policy team has summarized the year so far in policy at the Federal, State, and Regional levels.

regulatory

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.

Recent News

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.