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The Latest in Regulatory and Reimbursement
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Biocom California’s Regulatory Affairs Committee heard from FDA’s CDER and CBER about a new CMC pilot program and ARPA-H presented their funding and partnership opportunities to BCA members during a recent webinar. The FDA published a cross-center white paper on AI and the EPA finalized new requirements for ethylene oxide sterilizers. A CMS final rule is under review at the White House Office of Management and Budget and the agency opened registration for its upcoming health equity conference.
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ARPA-H’s T3X Director Presents to Biocom California
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On March 26, the Director of Technology Transfer and Transition (T3X) from the Advanced Research Projects Agency for Health (ARPA-H) spoke to the Biocom California community about ARPA-H funding, research, and engagement opportunities.
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Biocom California Committee Hosts FDA CMC Experts
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Biocom California’s Regulatory Affairs Committee learned first-hand about the FDA’s CMC Development & Readiness Pilot Program and its progress from CDER’s Division Director, Tanya Clayton, and CBER’s Associate Director for Policy and CMC expert, Dr. Ramjay Vatsan. |
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EPA NESHAP Rule Finalized with EtO Requirements
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Last month, the EPA released its final amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) which outlines new requirements for ethylene oxide (EtO) sterilizers. Biocom California commented on the proposed rule in June 2023. |
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FDA Publishes Multi-Center Artificial Intelligence Paper
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Medicaid Drug Rebate Final Rule Under OMB Review
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As of March 22, the Medicaid Drug Rebate Program (MDRP) final rule is under review at the Office of Management and Budget. The rule would finalize requirements related to manufacturers’ misclassification of covered outpatient drug products under the MDRP, beneficiary protections, and program administration changes. |
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Upcoming CMS 2024 Health Equity Conference
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Last month, registration opened for the 2024 CMS Health Equity Conference. The conference brings together stakeholders and federal and local agency leaders, health provider organizations, academia, and community-based organizations to hear from CMS leadership on recent developments and updates to health equity research. |
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Request for Comments
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Biocom California welcomes feedback from members on the following draft guidance by April 5. Click here to submit comments via email. |
- Assists sponsors of clinical trials in determining when a data monitoring committee (DMC), a data and safety monitoring committee (DSMC), or an independent data monitoring committee (IDMC)) would be useful for trial monitoring.
- Provides considerations for procedures and practices to guide the operation of data monitoring committees.
- Discusses independence of the DMC and includes FDA recommendations and regulatory reporting requirements.
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Upcoming Regulatory and Reimbursement Events:
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Featured Members
Congratulations to Dexcom on its FDA clearance of the first over the counter continuous glucose monitor!
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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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