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The Latest in Regulatory and Reimbursement
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Biocom California members met with FDA’s Center for Devices and Radiological Health (CDRH) and CMS’s Coverage and Analysis Group (CAG) as part of the 2024 Emerging Technologies Advocacy Fly-In and Biocom California submitted comment letters responding to two FDA draft guidance documents. CDER launched the Center for Clinical Trial Innovation and CDRH announced a new Health Care at Home initiative. CMS released a FY 2025 proposed rule for inpatient prospective payment systems and Medicare Administrative Contractors issued a new proposed local coverage determination for skin substitute products.
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Biocom California Meets with FDA CDRH & CMS Leadership
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As part of the Biocom California 2024 Emerging Technologies Advocacy Fly-In, members had the unique opportunity to meet with CDRH Director Jeff Shuren and CAG Director Tamarak Syrek-Jensen to discuss regulatory pathways, pilot programs, and reimbursement coverage policies.
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Comments Submitted on FDA Clinical Trial Guidances
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FDA Launches New Center for Clinical Trial Innovation
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The new CDER Center for Clinical Trial Innovation will share lessons learned from existing clinical trial innovation initiatives and will also manage a demonstration program to expand interactions between sponsors and CDER staff. |
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New FDA Health Care at Home Initiative Launched
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The new Home as a Health Care Hub initiative will reimagine the home environment as an integral part of the health care system and the hub will be designed as an Augmented Reality/Virtual Reality (AR/VR)-enabled home prototype. |
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MACs Issue Proposed LCD for Skin Substitute Products
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Last month, the Medicare Administrative Contractors (MACs) released a proposed Local Coverage Determination (LCD) to provide coverage for skin substitute grafts for chronic non-healing diabetic foot and venous leg ulcers. Comments on the proposed LCD are due June 8. |
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CMS Releases FY 2025 IPPS Proposed Rule
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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. |
- Recommendations for the design and analytical features of a non-interventional study for the purpose of demonstrating a drug’s safety and/or effectiveness.
- Discusses considerations for the proposed approach, study design, data sources, and statistical analysis.
- Non-interventional studies include observational cohort, case-control, and self-controlled studies.
This guidance may be of interest to sponsors and investigators of drug and biological products.
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Upcoming Regulatory and Reimbursement Events:
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Featured Members
Kura Oncology has been granted Breakthrough Therapy Designation from the FDA for its investigational drug, ziftomenib, for the treatment of patients with relapsed/refractory NPM1-mutant acute myeloid leukemia.
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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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