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The Latest in Regulatory and Reimbursement
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Robert F. Kennedy Jr. was sworn in as the 26th Secretary of the Department of Health and Human Services. The FDA published its drug safety priorities, GLP-1 medications are no longer on the drug shortage list and the agency granted an emergency use authorization for a COVID-19/Influenza test. CMS announced upcoming public engagements for the Medicare Drug Price Negotiation Program and funding was cut for the Affordable Care Act Navigator Program.
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New HHS Secretary Confirmed
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CDER Drug Safety Priorities Published
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Drug Safety Priorities FY 2024 describes key safety drug operations such as activities to address the national drug overdose crisis work to prevent medication shortages, and efforts to communicate about recalls and safety information to the public.
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GLP-1 Medication Shortage Resolved
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Semaglutide injection products were removed from the FDA’s drug shortage list. Pharmacies and facilities will have until April 22 and May 22, respectively, to end any compounding activities.
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FDA Grants EUA for OTC COVID/Flu Test
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Public Meetings for 2027 Drug Price “Negotiation” Cycle
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CMS will host public engagement opportunities surrounding the IRA’s 2027 negotiation cycle including a public town hall meeting on April 30 and 15 private patient-focused roundtable events from April 16-29. |
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Funding Reduced for ACA Navigator Program
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CMS announced a reduction in annual funding for the Affordable Care Act (ACA) Navigator Program, which is responsible for helping consumers navigate the ACA exchanges, to $10 million. |
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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Biocom California welcomes feedback from members on the following draft guidance document.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. |
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Upcoming Regulatory and Reimbursement Events:
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Featured Members
Congratulations to Sanofi on receiving FDA approval for its drug, Merilog, the first rapid-acting insulin biosimilar product for the treatment of diabetes.
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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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