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The Latest in Regulatory and Reimbursement
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Biocom California has submitted comments on the Medicare Drug Price Negotiation Program. FDA has been working to educate stakeholders on its COVID-19 transition policies for medical devices during a recent webinar, CDRH has launched a new sterilization pilot program, and the agency has announced a public workshop to discuss novel endpoints for rare disease drug development. The EPA has released two proposed rules to limit ethylene oxide emissions and CMS’s recent IPPS rule proposes changes to the New Technology Add-On Payment Program.
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Biocom California Comments on IRA Drug Price Negotiation Program
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On April 14, Biocom California submitted comments on the Inflation Reduction Act Medicare Drug Price Negotiation Program initial guidance. Thank you to our members for their continued engagement and thoughtful feedback on this important topic. |
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FDA Webinar on COVID-19 Transition Plans for Medical Devices
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FDA hosted a webinar on its COVID-19 transition plans for medical devices and discussed ways to submit a marketing application and the timeline to do so. For more information, see FDA’s meeting materials and webinar recording. |
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EPA EtO Proposed Rules
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The Environmental Protection Agency released two proposed rules, the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) and National Emission Standards for Hazardous Air Pollutants ( NESHAP), with provisions aimed at limiting ethylene oxide (EtO) emissions from medical device sterilizers. |
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New FDA Sterilization Pilot
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CDRH launched a new Radiation Sterilization Master File Pilot Program to allow companies that terminally sterilize single-use medical devices using gamma radiation or EtO to submit a Master File when making certain sterilization changes. CDRH is currently seeking up to nine participants for the pilot program. |
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RDEA Pilot Workshop Announced
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CMS releases FY 2024 IPPS Proposed Rule
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In the recently issued inpatient prospective payment system (IPPS) proposed rule, proposed changes to the New Technology Add-On Payment (NTAP) Program include requiring applicants to have an active FDA marketing application at the time of NTAP submission and moving up the FDA approval deadline to May 1. |
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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. |
- The limitations of single-arm trials for oncology drugs and how randomized controlled trials can be utilized to address these limitations.
- Design recommendations for randomized controlled and single-arm trials.
- Recommendations for confirmatory trials to demonstrate clinical benefit.
This guidance may be of interest to drug and biologics manufacturers.
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- Strategies for alternatives to traditional human or animal research for product development, use of real-world evidence (RWE) to understand healthcare gaps, and ideas for how to scale novel therapies.
- Proposed models for how ARPA-H can support projects to make safer, more effective solutions while facilitating a path to market.
- Case studies on the development of innovative technologies and opportunities for R&D innovation that highlight best practices and use of existing FDA regulatory pathways.
This RFI may be of interest to all Biocom California members.
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Upcoming Regulatory and Reimbursement Events:
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Featured Members
Biocom California members, Bristol Myers Squibb and Foundation Medicine, have recently expanded their collaboration efforts to develop Foundation Medicine’s companion diagnostic for BMS’s investigational cancer therapy.
Congratulations to Biogen on the approval of their drug, Qalsody (tofersen), to treat patients with amyotrophic lateral sclerosis (ALS).
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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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