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The Latest in Regulatory and Reimbursement
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Biocom submitted feedback on the Prescription Drug User Fee (PDUFA) VIII commitment letter and on the Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway. FDA finalized a new guidance on prescription drug apps, launched an initiative to develop a rare disease regulatory framework and announced a new development program focused on neuroscience. CMS issued a proposed rule to reform parts of the Medicare Advantage and Part D programs, and the agency awarded funding to California as part of the Rural Health Transformation Program.
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Biocom Submits Comment Letters to FDA and CMS
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FDA Finalizes Guidance on Prescription Drug Apps
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Biocom responded to the FDA’s PDUFA VIII commitment letter and submitted comments on CMS’s RAPID Coverage Pathway for breakthrough technologies.
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FDA issued final guidance clarifying when content from apps used with prescription drugs is considered part of the FDA-required and promotional labeling.
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FDA Launches New Rare Disease Framework Initiative
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New FDA Neuroscience Development Program
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FDA’s new Rare Disease Framework Initiative aims to develop a fit-for-purpose framework for rare disease drug and biologic development. The agency hosted a public meeting last month to solicit feedback on the initiative and comments are due by December 11. |
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FDA launched the Neuroscience Advancement and Innovation Nexus, a cross-center program to advance the development of neurologic and psychiatric medical products, beginning with an initiative focused on delaying and preventing Alzheimer’s disease. |
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CMS Proposes Medicare Advantage and Part D Reforms
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California Receives Rural Healthcare Funding
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CMS issued a proposed rule implementing the Consolidated Appropriations Act, 2026 provisions on Medicare Advantage provider directory accuracy, Part D pharmacy benefit manager transparency and compensation and cost sharing for low-income beneficiaries, beginning in 2028.
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California received more than $233 million in Rural Health Transformation Program funding from CMS to improve healthcare access across the state. This investment will help rural providers deliver and coordinate care through regional networks and upgraded healthcare technology. |
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Request for Comments
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Biocom welcomes feedback from members on the following FDA framework initiative. Click here to submit comments via email. |
► On October 28, FDA hosted the FDA Rare Disease Framework Initiative public meeting. The Agency is seeking comments within these topic areas regarding CDER and CBER’s roles in rare disease drug development and review.
- Fit-for-purpose review of rare disease therapies based on attainable evidence, particular disease state and population.
- Consistency and predictability of FDA’s rare disease drug development and review regulatory requirements.
- FDA engagements with external parties — including patients, disease experts and researchers — to inform review decision-making for rare disease therapies.
- Considerations for chemistry, manufacturing and controls (CMC) specific to rare disease therapies.
This meeting is of particular interest to drug and biologic developers.
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Upcoming Regulatory and Reimbursement Events:
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Featured Member
Congratulations to Biocom member GSK on receiving the FDA’s accelerated approval of Jemperli (dostarlimab-gxly) as a standalone treatment for adults with previously untreated stage II or III locally advanced dMMR or MSI-H rectal cancer, allowing certain patients to avoid chemotherapy, radiation and surgery.
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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.
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San Diego | Bay Area | Los Angeles | Seattle | Sacramento | Washington D.C. | Tokyo
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Biocom Headquarters
10996 Torreyana Road, Suite 200, San Diego, CA 92121
Bay Area
1 Tower Place, Suite 150, South San Francisco, CA 94080
Los Angeles
15260 Ventura Blvd., Suite 725, Sherman Oaks, CA 91403
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