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The Latest in Regulatory and Reimbursement
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Biocom California submitted comments on a cell and gene therapy FDA draft guidance and a longstanding agency official announced their retirement. The FDA issued its action plan for the distributed manufacturing of drugs and a final rule amending advertising regulations for prescription drugs. CMS finalized its Medicare Part D Manufacturer Discount Program guidance, and the Medicare Drug Price Negotiation timeline continues with initial offers due early next year.
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Biocom California Comments on C> FDA Draft Guidance
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Biocom California submitted comments on the FDA’s draft guidance document, Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products. Thank you to our members for their valuable feedback! |
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FDA’s Principal Deputy Commissioner to Retire
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After a 40-year FDA career, Principal Deputy Commissioner Dr. Janet Woodcock is set to retire in early 2024. FDA’s Chief Scientist Dr. Namandjé Bumpus is slated to assume her role. Thank you, Dr. Woodcock, for your service to public health! |
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New Action Plan for Drug Distributed Manufacturing
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Final Rule Amending FDA’s Drug Advertising Regulations
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The agency has issued a final rule amending its prescription drug advertising regulations to require that a drug’s side effects and contraindications be presented in a clear, conspicuous, and neutral manner in TV and radio ads. |
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Part D Manufacturer Discount Program Guidance Finalized
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IRA Medicare Drug Price Negotiation Timeline
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After concluding its patient-focused listening sessions last month, CMS has until February 1, 2024, to provide a maximum fair price initial offer and concise justification to manufacturers for selected drugs. |
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Request for Comments
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Biocom California welcomes feedback from members on the following comment opportunity. Click here to submit comments via email. |
- What are the key challenges or barriers that may hinder the implementation and adoption of innovative approaches in clinical trial design, conduct, and execution?
- Are there specific actions that CDER or others could take to enhance implementation and adoption of innovative approaches in clinical trial design, conduct, and execution?
- Do certain therapeutic areas or types of trials face unique barriers or challenges to implementing innovative approaches?
This guidance may be of interest to drug and biological product developers.
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Upcoming Regulatory and Reimbursement Events:
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Thank You Members
Congratulations to all our members who have worked to advance health through transformative innovations over the last year. We thank you for your commitment to accelerating the life sciences and your work is what empowers California to propel forward as the leader in biotechnology. Thank you and happy holidays!
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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 {{{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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