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The Latest in Regulatory and Reimbursement
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Biocom California submitted comments on an FDA draft guidance document. The federal government reopened after a 43-day shutdown and agency operations have resumed. The FDA has a new director of its Center for Drug Evaluation and Research (CDER). The agency awarded additional Commissioner’s National Priority Vouchers and FDA leadership released details about a new regulatory pathway for n-of-1 therapies. CMS announced the launch of a new model to negotiate Medicaid drug costs early next year.
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Biocom Comments on FDA Draft Guidance
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Longtime FDA Oncology Leader Now Directing CDER
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FDA’s longtime director of the Oncology Center of Excellence, Dr. Richard Pazdur, will now lead the agency’s Center for Drug Evaluation and Research. |
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Government Reopens & Agency Operations Resume
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On November 12, President Trump signed legislation reopening the federal government. The bill funds the FDA until the end of the fiscal year and the agency is once again able to accept new applications. |
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FDA Announces Additional CNPV Recipients
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The FDA announced an additional six awardees under the Commissioner’s National Priority Voucher (CNPV) pilot program, bringing the total to 15 vouchers awarded thus far. |
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New Details about Plausible Mechanism Pathway
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Drs. Makary and Prasad published an article outlining five main principles of FDA’s new “Plausible Mechanism” Pathway. A pathway for approving therapies where a randomized trial is not feasible. |
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CMS Launches New Model to Negotiate Medicaid Drug Costs
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The GENEROUS model, which launches in January 2026, will allow state Medicaid programs to purchase drugs included in the pilot at prices aligned with those paid in other countries. |
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