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The Latest in Regulatory and Reimbursement
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Biocom California submitted comments on real-world evidence to support medical device regulatory decisions. The FDA has released a draft guidance on MDUFA Small Business Fee Waivers and the agency’s Center for Drug Evaluation and Research has issued a drug safety priority report. CMS has published an additional guidance related to its Medicare Prescription Payment Plan and has updated its Inflation Reduction Act website with additional program materials.
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Biocom California Comments on Real-World Evidence
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MDUFA Small Business Fee Waiver Guidance Released
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In a new draft guidance, the FDA describes plans to implement the Small Business Fee Waiver system to waive the annual registration fee for small businesses undergoing financial hardships.
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FDA Funding Continued through March 8
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A FDA shutdown was avoided last week when Congress passed a short-term Continuing Resolution, signed into law on March 1, that would continue current appropriations levels through March 8 for the agency.
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CDER Releases Drug Safety Priorities
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CMS Updates Inflation Reduction Act Website
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First Final Guidance Issued for Medicare Rx Payment Plan
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CMS finalized its part one guidance for the new Medicare Prescription Payment Plan, establishing final policies for CY 2025 including the calculation of the monthly maximum cap and pharmacy requirements.
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Upcoming Regulatory and Reimbursement Events:
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Featured Members
The FDA granted Iovance Biotherapeutics accelerated approval for lifileucel, a tumor-derived autologous T cell immunotherapy, for adult patients with unresectable or metastatic melanoma.
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Biocom California
For over 28 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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