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The Latest in Regulatory and Reimbursement
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Biocom California members met with high-level regulators as part of our Energy and Agriculture Biotech Fly-in. FDA has announced DSCSA exemptions for certain COVID-19 products, the Oncology Center of Excellence has launched a new project focused on diverse populations affected with cancer, and Biocom California has responded to the FDA’s discussion paper on artificial intelligence in drug manufacturing. CMS has released a new Minority Research Grant Program Funding Opportunity and a proposed rule for the Medicaid Drug Rebate Program.
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Biocom California Energy & Ag Biotech Fly-In
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In early May, Biocom California hosted California executives in Washington, D.C., for the 2023 Energy and Agriculture Biotech Fly-In. Members had the unique opportunity to meet and discuss their priorities with the EPA, OSTP, FDA, and USDA. |
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Biocom California Comments on AI in Drug Manufacturing
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DSCSA Exemptions for Some COVID-19 Products
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At the end of the public health emergency, FDA published a letter announcing exemptions for covered COVID-19 products from certain requirements in the Drug Supply Chain Security Act (DSCSA). These exemptions would help maintain public health and avoid potential supply chain disruptions. |
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OCE’s New Research Diversity Program
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Project ASIATICA, a new program from FDA’s Oncology Center of Excellence, will focus on bringing greater awareness and understanding of the challenges faced by Asian American, Native Hawaiian, and other Pacific Islanders with cancer, which is the leading cause of death for these populations in the U.S.
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CMS Funding Opportunity for Health Care Disparities
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The CMS Minority Research Grant Program will award up to three grants, totaling up to $333,000 each, to researchers at eligible minority-serving institutions who are investigating or addressing health care disparities affecting CMS focus populations. |
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Medicaid Drug Rebate Program Proposed Rule
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Request for Comments
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Biocom California welcomes feedback from members on the following opportunity. Click here to submit comments via email. |
- DCT design, the use of digital health technologies and software, and remote clinical trial visits.
- Sponsor and investigator roles and responsibilities.
- Informed consent and IRB oversight of DCTs.
- The use of investigational products in a DCT and their packaging and shipping.
This draft guidance may be of interest to 1) sponsors and investigators of drugs, biological products, and devices, 2) clinical research organizations, 3) clinical management and regulatory teams.
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Upcoming Regulatory and Reimbursement Events:
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Featured Members
Congratulations to Opiant Pharmaceuticals on its recent FDA approval of Opvee, the first nalmefene hydrochloride nasal spray for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older.
The FDA granted approval to GSK for Arexvy, the first respiratory syncytial virus (RSV) vaccine approved for use in the United States. Arexvy is approved for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older.
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Biocom California
For over 28 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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