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The Latest in Regulatory and Reimbursement
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Biocom California submitted comments on a proposed LCD, the FDA has released its long-awaited draft guidance on diversity action plans and international regulators published guiding principles for machine learning-enabled medical devices. Additionally, CDER launched an Emerging Drug Safety Technology Program, the FDA issued a final rule revising requirements for medical gases and CMS announced the Medicare Part B drugs with reduced coinsurance rates under the Inflation Rebate Program.
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Biocom California Comments on Skin Substitutes LCD
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New FDA Guidance on Diversity in Clinical Trials
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International Regulators Publish ML Guiding Principles
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CDER Focuses on Drug Safety Technology
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FDA Establishes New Regulations for Medical Gases
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The agency released a final rule revising current good manufacturing practices, postmarketing safety reporting and labeling requirements for certain medical gases and establishing regulations for certifying designated gases. |
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CMS Reduced Coinsurance for Part B Rebatable Drugs
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CMS announced they have identified 64 Medicare Part B prescription drugs that enrollees will pay less for under the Medicare Prescription Drug Inflation Rebate Program since these drug prices were raised faster than the inflation rate. |
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Request for Comments
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Biocom California welcomes feedback from members on the following draft guidance document. Click here to submit comments via email. |
- Discusses eligibility factors for receiving a platform technology designation, potential benefits of the designation and how to leverage data from designated platform technologies.
- Definitions of a “designated platform technology” and “platform technology.”
- Outlines the process for discussing a planned designation request as part of a milestone meeting, the recommended content of a designation request submission and the review timelines for a designation request.
This guidance may be of interest to developers of drug and biological products.
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Upcoming Regulatory and Reimbursement Events:
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Featured Members
The FDA has granted accelerated approval to Biocom California member, Mirati Therapeutics, for its drug adagrasib plus cetuximab for adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer.
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Biocom California
For over 29 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 {{{dynamic_content_1600}}} 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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