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The Latest in Regulatory and Reimbursement
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Biocom California unveiled user fee infographics for PDUFA VII, MDUFA V, and BsUFA III. The FDA hosted its annual rare disease day, a prominent FDA director announced his retirement, and the agency recently released a new funding opportunity for pediatric medical devices. CMS held a MEDCAC meeting to review coverage with evidence development requirements, and CMMI plans to test three drug payment models in response to the administration’s executive order on lowering prescription drug costs.
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Biocom California Unveils FDA User Fee Infographics
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The PDUFA VII, MDUFA V, and BsUFA III infographics provide backgrounds, accomplishments, goals, and timelines for each user fee agreement that was signed into
law last year. |
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FDA Rare Disease Day
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On February 27, FDA hosted its Rare Disease Day focused on advancing therapeutic product development, overcoming clinical trial challenges, and learning about patient perspectives. |
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OTAT Director Retiring
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Dr. Wilson Bryan, Director of the FDA’s Office of Tissue and Advanced Therapies (OTAT), announced he will retire at the end of March. Dr. Bryan spent more than 20 years with the FDA. |
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New Funding Opportunity for Pediatric Medical Devices
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A new FDA funding opportunity, open until March 29, through the Pediatric Device Consortia grants program aims to advance the development of medical devices for children. |
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CMMI Responds to Drug Pricing EO
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Three new drug payment models, focused on generics, cell and gene therapies, and accelerated approval drugs, have been selected for testing by the CMS Innovation Center (CMMI) in response to the President’s Executive Order (EO) on lowering prescription drug costs. |
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CMS MEDCAC Meeting
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On February 13 and 14, CMS convened the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) to examine requirements for clinical studies covered under Coverage with Evidence Development (CED). Download the meeting summary for more information. |
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Request for Comments
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Biocom California welcomes feedback from members on the following FDA draft guidance document. Click here to submit comments via email. |
- This guidance provides recommendations for the use of externally controlled trials to provide evidence of drug safety and effectiveness.
- In an externally controlled trial, outcomes are compared between participants receiving the test treatment and a group of people external to the trial who had not received the treatment.
- The external control arm can be a group of people, treated or untreated, from an earlier time (historical control) or during the same time period (concurrent control) but in another setting.
This guidance may be of interest to drug and biologic manufacturers.
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Upcoming Regulatory and Reimbursement Events:
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Featured Members
Congratulations to Travere Therapeutics on receiving FDA accelerated approval for FILSPARI (sparsentan), the first and only non-immunosuppressive therapy intended to reduce proteinuria in adults with IgA Nephropathy.
The FDA recently approved Sanofi’s Biologics License Application supplement for the approval of its Fluzone influenza vaccine for the 2023 season.
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Biocom California
For over 27 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 1,700 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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