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The Latest in Regulatory and Reimbursement
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Biocom submitted feedback on FDA’s new Plausible Mechanism Framework and President Trump nominated a former Deputy Surgeon General as CDC director. The FDA has announced new advancements in real-time clinical trials and a new coverage pathway for breakthrough devices. The scope of the FDA’s TAP Pilot Program has expanded and CMS has proposed to repeal an alternative pathway for New Technology Add-on Payments.
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Biocom Comments on FDA Draft Guidance
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President Trump Nominates New CDC Director
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President Trump nominated former Deputy Surgeon General, Erica Schwartz, M.D., to be director of the Centers for Disease Control and Prevention (CDC). |
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FDA Advances Real-Time Clinical Trials (RTCT)
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The FDA announced the initiation of two proof-of-concept clinical trials that will report endpoints and data signals in real time and released a RFI regarding a proposed RTCT pilot program that will begin this summer. |
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FDA’s TAP Pilot Program Continues to Expand
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Starting May 1, FDA’s Total Product Life Cycle Advisory Program (TAP) will accept enrollment requests for renal, gastrointestinal, obesity, and transplant devices (reviewed by DHT3A) and surgical and infection control devices (via OHT4). |
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New RAPID Coverage Pathway Announced for Devices
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Payment Changes Proposed for Breakthrough Devices
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Request for Comments
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The FDA is seeking public comments on the Commissioner’s National Priority Voucher Pilot (CNPV) Program. Biocom welcomes feedback from members on the following aspects of the CNPV program. Click here to submit comments. |
- The program’s eligibility criteria and the voucher selection process
- Sponsor reponsibilities and the pre-submission requirements
- FDA review procedures and the role of the CNPV Review Council
- Other aspects of the program’s implementation
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Upcoming Regulatory and Reimbursement Events:
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Featured Members
Congratulations to Biocom member, Travere Therapeutics, on the FDA approval of their drug, Filspari, to reduce proteinuria in adult and pediatric patients aged 8 years and older with focal segmental glomerulosclerosis (FSGS).
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Biocom Policy & Advocacy
Biocom is the leading advocate for California’s life science sector. Our Policy & Advocacy staff across the Bay Area, Los Angeles, San Diego, Sacramento and Washington, D.C. work with lawmakers and regulators to shape policy and strengthen government relations through coordinated regional, state and federal engagement, supporting industry growth and keeping California globally competitive.
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