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The Latest in Regulatory and Reimbursement
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FDA Commissioner Makary revealed the President’s proposed FY26 budget for the agency. The FDA announced plans to expand unannounced foreign inspections, increase the use of AI in its scientific reviews and enhance state drug importation programs. The FDA’s Center for Biologics Evaluation and Research has a new director and the Make America Healthy Again Commission published its first report.
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President’s Proposed FY26 FDA Budget
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Commissioner Makary announced that the Trump Administration is proposing a $6.8B budget for the FDA for fiscal year (FY) 2026 with $3.2B in budget authority and $3.6B in user fees. |
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New FDA CBER Chief Announced
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Dr. Vinay Prasad, epidemiology professor from the University of California San Francisco, was named as FDA’s new director of the Center for Biologics Evaluation and Research. |
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Expanded Use of Unannounced Inspections
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The FDA will expand unannounced inspections at foreign manufacturing facilities and update investigator travel policies to ensure equal oversight between domestic and foreign companies. |
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Agency Scales AI-Assisted Scientific Review
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FDA Commissioner Makary announced an effort to scale the use of generative artificial intelligence (AI) tools across all FDA centers by June 30 to help streamline review processes. |
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FDA Updates to Support State Drug Importation Programs
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First MAHA Commission Report Released
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The Make America Healthy Again (MAHA) Commission published its report focused on the role of ultra-processed foods, chemicals, medication and lifestyle choices in childhood health. |
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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Biocom California welcomes feedback from members on the following draft guidance document.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 Biocom California member, Abbvie, on receiving FDA approval for its first in line cancer treatment, Emrelis, for the treatment of Non-Small Cell Lung Cancer with high c-Met overexpression in adults who have received prior systemic therapy.
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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. 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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