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The Latest in Regulatory and Reimbursement
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Biocom California hosted Dr. Peter Marks, FDA’s Director of the Center for Biologics Evaluation and Research (CBER), at a recent committee meeting and submitted comments on the agency’s Platform Technology Program draft guidance. The FDA approved and authorized updated mRNA COVID-19 vaccines and announced a new funding opportunity for rare neurodegenerative disease research. CMS finalized the Transitional Coverage for Emerging Technologies (TCET) pathway and released the “negotiated” prices of the first 10 drugs selected for the IRA’s Medicare Drug Price Negotiation Program.
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Biocom California Hosts CBER Director Dr. Peter Marks
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On August 22, Biocom California’s Regulatory Affairs Committee (RAC) and Cell and Gene Therapy (CGT) committee gathered in SF, SD and on Zoom to hear from CBER Director Dr. Peter Marks about the FDA’s CGT initiatives and regulatory policy. |
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Biocom California Comments on Platform Technologies
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FDA Authorizes Updated COVID-19 Vaccines
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New FDA Rare Disease Funding Opportunity
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The FDA announced a new funding opportunity for the Rare Neurodegenerative Disease Grant Program to fund clinical trials evaluating efficacy and/or safety in support of a new indication or change in labeling to address unmet needs. Applications are due by October 22. |
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CMS Finalizes Transitional Coverage Pathway for Devices
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CMS Announces “Negotiated” Drug Prices for 2026
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Request for Comments
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Biocom California welcomes feedback from members on the following discussion paper and draft guidance. Click here to submit comments via email. |
► Discussion Paper: Health Equity for Medical Devices
CDRH describes factors and considerations that may be important for sponsors as they develop medical device clinical studies. The FDA poses questions to facilitate feedback on the following items:
- Three considerations: (disease burden or condition; physiology, anatomy and pathophysiology; and technology) that may help inform the clinical study design.
- Two important areas of consideration when evaluating whether clinical data are generalizable and representative of the intended use population identified for a particular device.
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► Predetermined Change Control Plans for Medical Devices
This draft guidance proposes a policy for predetermined change control plans (PCCPs) including:
- Guiding principles for PCCPs
- Examples and types of modifications for PCCPs
- Recommendations on the information to include in a PCCP in a marketing submission
Both documents may be of interest to medical device manufacturers.
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Upcoming Regulatory and Reimbursement Events:
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Featured Members
Congratulations to Biocom California member ARS Pharmaceuticals on the FDA approval of its product, neffy. Neffy is the first epinephrine product for the treatment of anaphylaxis that is not administered by injection.
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Biocom California
For over 29 years, Biocom California has helped move the life science industry forward with transformative resources that enable companies to make meaningful connections. With a membership base of over {{{dynamic_content_1600}}} companies, we connect our members to each other so they can collaborate and work stronger and smarter together. We connect organizations to capital investment and purchasing solutions so they can grow faster and work more efficiently. We’re their link to advocacy that fights for innovation and we provide an environment where their business and talent can thrive. Biocom California is how the life science industry gets connected.
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