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The Latest in Regulatory and Reimbursement
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Biocom California hosted a speaker from the FDA’s Center for Clinical Trial Innovation at a recent committee meeting and submitted comments on the agency’s Diversity Action Plan draft guidance. The FDA published a digital health and artificial intelligence glossary ahead of the agency’s first digital health advisory committee meeting next month. FDA’s CDER has accepted an organ-on-a-chip technology into its ISTAND pilot program. CMS released its final rule on the Medicare Drug Rebate Program and published its final guidance for the Medicare Drug Price Negotiation Program for Initial Price Applicability Year 2027.
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Biocom California Hears from FDA’s C3TI Associate Director
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On September 10, Biocom California’s Regulatory Affairs Committee heard from CDER’s Center for Clinical Trial Innovation (C3TI) about the center’s mission and efforts to expand and support innovative clinical trial approaches for drug development programs.
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Biocom California Comments on Diversity Action Plans
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New FDA Digital Health Glossary and Advisory Committee Meeting
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First Organ-on-a-Chip Technology Accepted into ISTAND Pilot
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Medicaid Drug Rebate Program Final Rule Released
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CMS Publishes Final “Negotiation Program” Guidance for 2027
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Request for Comments
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Biocom California welcomes feedback from members on the following draft guidance documents. Click here to submit comments via email. |
► Predetermined Change Control Plans for Medical Devices
FDA’s draft guidance proposes a policy for Predetermined Change Control Plans (PCCPs) and includes recommendations on the information to include in a PCCP in a device marketing submission.
- A PCCP is the documentation describing what modifications will be made to a device and how the modifications will be assessed.
- A PCCP should describe the planned device modifications, the methodology to develop, validate and implement those modifications, and an assessment of the impact of those modifications.
- FDA reviews the PCCP as part of a marketing submission and the recommendations in this draft guidance apply to devices reviewed through the 510(k), De Novo and PMA pathways.
This guidance may be of interest to device manufacturers.
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► Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice
- The draft guidance supports the conduct of randomized controlled drug trials with streamlined protocols and procedures that integrate research into routine clinical practice (i.e., point-of-care trials or large simple trials).
- These RCTs may improve convenience and accessibility for participants and allow for enrollment of more representative populations.
- Leveraging healthcare institutions and existing clinical expertise in the medical community can reduce trial startup times and speed up enrollment.
This guidance may be of interest to clinical trial sponsors of drug and biological products.
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Upcoming Regulatory and Reimbursement Events:
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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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