The Latest in Regulatory and Reimbursement

Biocom submitted feedback on the FDA’s National Priority Voucher Pilot Program. President Trump has nominated CMS Medicare Director, Chris Klomp, to be HHS Deputy Secretary. The FDA has proposed to establish a new pilot program to shorten the time it takes from drug identification to first-in-human study and the Agency announced the selection of seven participants for its PreCheck Pilot Program. The acting director of CBER’s Office of Therapeutic Products will be stepping down from their position and CMS has proposed a permanent framework for the Medicare Drug Price Negotiation Program.

Request for Comments

Biocom welcomes feedback from members on the following FDA draft guidance document. Click here to submit comments via email.

► Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing 

• FDA’s current thinking on the type of prior knowledge that may be scientifically appropriate to leverage to advance product development.
• Recommendations include how to leverage chemistry, manufacturing and controls (CMC); nonclinical; and clinical prior knowledge to increase review efficiency.

This guidance would be of interest to gene therapy developers.

Featured Members

Congratulations to Biocom members, Cellares Corp, Eli Lilly and Company and Kyowa Kirin, on being selected to participate in the FDA’s PreCheck Pilot Program.

Biocom Policy & Advocacy

Biocom is the leading advocate for California’s life science sector. Our Policy & Advocacy staff across the Bay Area, Los Angeles, San Diego, Sacramento and Washington, D.C. work with lawmakers and regulators to shape policy and strengthen government relations through coordinated regional, state and federal engagement, supporting industry growth and keeping California globally competitive.