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The Latest in Regulatory and Reimbursement
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President-elect Donald Trump indicated he will nominate Dr. Martin Makary and Dr. Mehmet Oz to be heads of FDA and CMS. CMS proposed technical and policy changes to Medicare Advantage and Medicare Prescription Payment Program and two manufacturers agreed to participate in CMS’s Cell and Gene Therapy Access Model. FDA’s CDRH launched a communications pilot for high-risk medical device recalls. The FDA finalized guidance on predetermined change control plans for artificial intelligence device software functions and sterilization site changes for Class III devices.
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FDA Commissioner and CMS Administrator Selected
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President-elect Donald Trump selected Dr. Marty Makary and
Dr. Mehmet Oz to lead the FDA and CMS, respectively. Both Drs. Makary and Oz will need to undergo Senate confirmation before assuming their roles. |
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CMS Proposes Policy and Technical Changes
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CMMI Cell & Gene Therapy Access Model Updates
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New CDRH Communications Pilot for Device Recalls
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CDRH is launching a new pilot to improve the communication of high-risk medical device removals and corrections related to cardiovascular, gastrorenal, general hospital, obstetrics and gynecology, and urology devices. |
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New PCCP Guidance for AI/ML Devices Finalized
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FDA Issues New EtO Sterilization Guidance
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This guidance provides transitional enforcement discretion for Class III devices in order to mitigate the risk of device supply chain disruptions while ethylene oxide (EtO) sterilization facilities transition to comply with new Environmental Protection Agency requirements. |
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Request for Comments
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Biocom California welcomes feedback from members on the following draft guidance document. Click here to submit comments via email. |
► FDA Draft Guidance: Accelerated Approval – Expedited Program for Serious Conditions
- Accelerated approval is an expedited program intended to facilitate and expedite development and review of new drugs to address an unmet medical need in the treatment of a serious or life-threatening condition.
- This draft guidance discusses threshold criteria to qualify a drug as a candidate for accelerated approval.
- This guidance also describes the procedures for expedited withdrawal of approval of a product approved under accelerated approval.
This guidance may be of interest to developers of drugs and biological products.
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Upcoming Regulatory and Reimbursement Events:
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Thank You Members
Congratulations to all our members who have worked to advance health through transformative innovations over the last year. We thank you for your commitment to accelerating the life sciences. Happy holidays!
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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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