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The Latest in Regulatory and Reimbursement
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With its Broad Agency Announcement Day near, the FDA has published initiatives for advancing regulatory science research and development. The agency’s Cybersecurity Modernization Action Plan has been released, and in a recent report the FDA highlighted its successful use of computational modeling and simulation for regulatory decision making. The agency clarifies its “device” definition versus “counterfeit device” in a new FDA final guidance. Starting January 1, 2023, certain provisions from the Inflation Reduction Act go into effect and biosimilar “skinny labels” are saving Medicare billions.
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FDA Releases FY 2023 Broad Agency Announcement (BAA)
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FDA published its BAA for Advanced Research and Development of Regulatory Science. For funding consideration in FY 2023, white papers are due January 23, 2023. |
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Final Guidance Clarifying “Device” Definition
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The FDA has released a final guidance clarifying its definition of devices versus counterfeit devices in alignment with the definitions used in the 2021 Safeguarding Therapeutics Act. |
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New FDA Cybersecurity Modernization Plan Released
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Computational Modeling & Simulation (M&S) for FDA
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IRA Provisions That Go into Effect in January 2023
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Beginning January 1, 2023, Medicare Part D beneficiaries’ out-of-pocket costs for a one-month supply of insulin will be capped at $35 and deductibles won’t apply to insulin. Part D-covered adult vaccines (shingles and Tdap) will be available at no cost to Medicare beneficiaries.
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“Skinny Labels” for Biosimilars Saves Medicare Billions
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According to a recent study published in JAMA Internal Medcine, “skinny labels” (i.e. regulatory approvals for limited indications) on about 22 biosimilars cut Medicare’s spending by an estimated $1.5 billion over a five-year period from 2015 to 2020. |
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Request for Comments
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Biocom California welcomes feedback from members on the following draft guidance documents. Click here to submit comments via email as soon as possible.
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- RDEA will provide sponsors with additional opportunities to engage with the FDA through early meetings to discuss efficacy endpoint development for rare disease drug and biological products.
- Sponsors admitted to the program can have up to four meetings with CDER or CBER.
- To promote innovation, novel efficacy endpoints developed through the RDEA Pilot Program may be presented by FDA as case studies, including while the drug studied in the trial has not yet been approved by FDA.
This guidance may be of interest to sponsors and manufacturers of drug and biological products.
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Upcoming Regulatory and Reimbursement Events:
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Thank You to Our Members
Congratulations to all our members who have worked to advance health through transformative innovations over the last year. We thank you for your commitment to accelerating the life sciences and your work is what empowers California to propell as the leader in biotechnology. Thank you and happy holidays!
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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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