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The Latest in Regulatory and Reimbursement
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Biocom California hosted a roundtable with the FDA’s new director of the Digital Health Center of Excellence and held a recent webinar on the Inflation Reduction Act’s prescription drug pricing reform. The FDA has begun accepting requests from drug and biologics manufacturers to participate in a new Chemistry, Manufacturing, and Controls Readiness pilot program, a digital health technology framework for drug and biological product development was recently released, and the agency determined which COVID-19 guidance documents will sunset with the end of the public health emergency in May. CMS recently published its initial guidance for the Medicare Drug Price Negotiation Program and announced the first Medicare Part B drugs which will be subject to
inflation rebates.
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Roundtable with FDA Director of Digital Health Center
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On March 9, Biocom California hosted a roundtable with Troy Tazbaz, FDA’s new director of the Digital Health Center of Excellence. Director Tazbaz spoke about his new role and the center’s strategic priorities. Read the full story. |
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IRA Drug Pricing Reform Webinar
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COVID-19 FDA Guidance Updates
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In a recent FR notice, FDA announced that certain COVID-19 guidance documents will no longer be in effect once the public health emergency ends on May 11. The agency also finalized two guidances outlining transition plans for devices with EUAs and enforcement policies. |
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FDA CMC Pilot Accepting Requests
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DHTs for Drug Development
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CMS Announces 27 Drugs for IRA Price Controls
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Under the Inflation Reduction Act, CMS announced the first 27 Medicare Part B drugs, which are single source drugs and biological products, whose manufacturers will be required to pay inflation rebates in 2025 due to drug prices outpacing inflation. |
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Request for Comments
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Biocom California welcomes feedback from members on the following opportunities. Click here to submit comments via email. |
- Terms and conditions contained in the manufacturer’s negotiation agreement.
- Manufacturer-reported data elements and evidence about alternative treatments.
- Negotiation and dispute resolution processes between CMS and manufacturers.
- The explanation for the maximum fair price and the method for applying the maximum fair price across different dosage forms and strengths of a selected drug.
- Processes for compliance monitoring and imposition of civil monetary penalties for violations.
This guidance may be of interest to drug and biologics manufacturers.
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- FDA presents 5 main areas for consideration and potential policy development for the use of AI technologies in drug manufacturing.
- These topics include cloud applications, data generation and management practices, regulatory oversight of AI and continuously learning AI systems, and standards for developing and validating AI models.
- The agency requests public feedback on 8 questions listed at the end of the discussion paper.
This guidance may be of interest to drug manufacturers.
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Upcoming Regulatory and Reimbursement Events:
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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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