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The Latest in Regulatory and Reimbursement
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A new FDA Acting Commissioner has been named and the agency announced a new Acting Director for the Center for Drug Evaluation and Research (CDER). CMS published the list of the next 15 drugs selected for the Medicare Drug Price Negotiation Program. The FDA launched a new Drug Supply Chain Security Act (DSCSA) townhall series, released its CBER 2024 annual report, and has a real-world evidence program submission deadline approaching.
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FDA Acting Commissioner
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Sara Brenner, who has been with the FDA since September 2019 as the associate director for medical affairs and chief medical officer for in vitro diagnostics, has been named as Acting Commissioner.
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CDER Change of Leadership
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CMS Published Next 15 Drugs for Price Negotiations
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CMS selected the next 15 drugs for the Medicare Drug Price Negotiation Program and these drug manufacturers will have until February 28 to sign agreements to participate in the program. |
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FDA DSCSA Town Hall Series Announced
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The Partnership for DSCSA Governance (PDG) and the FDA have three upcoming town halls to discuss DSCSA implementation efforts before the exemption periods end. |
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FDA’s CBER CY 2024 Annual Report Released
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Upcoming RWE Program Submission Deadline
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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Biocom California welcomes feedback from members on the following draft guidance documents.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. |
► Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway
- FDA’s accelerated approval authority as part of the Food, Drug, and Cosmetics Act.
- The agency’s interpretation of the term “underway”, and policies for implementing this requirement.
- Factors FDA intends to consider when determining whether a confirmatory trial is underway prior to accelerated approval.
This guidance may be of interest to sponsors of drugs and biological products.
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Upcoming Regulatory and Reimbursement Events:
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Featured Members
Congratulations to Inflammatix for the FDA clearance of their device, TriVerity™ Test System (TriVerity), a first-in-class molecular test for patients with suspected acute infection or sepsis.
Congratulations to Vertex Pharmaceuticals for their FDA approval of JOURNAVX™, an oral, non-opioid pain signal inhibitor for the treatment of adults with moderate-to-severe acute pain.
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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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