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The Latest in Regulatory and Reimbursement
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Biocom California issued a statement in response to CMS’s selection of drugs subject to “negotiation” and submitted comments on a proposed coverage pathway for emerging technologies. The FDA delayed certain Drug Supply Chain Security Act (DSCSA) requirements for another year, released a highly anticipated final guidance on real world evidence, and sent a proposed rule for laboratory developed tests to the White House for review.
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Biocom California’s Statement on Drugs Selected for IRA Price Setting
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Biocom California issued a statement responding to the release of the first ten drugs subject to IRA price controls and highlighted their devastating impact on the life science innovation ecosystem.
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First 10 Drugs Selected for Drug Price Negotiation Program
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On August 29, CMS published a list of the first 10 Medicare Part D drugs selected for negotiation for 2026. Manufacturers of selected drugs will have until October 1 to sign agreements to participate in the Negotiation Program.
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Biocom California Comments on Proposed TCET Pathway
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Delayed Enforcement of Certain DSCSA Requirements
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The FDA recently released two DSCSA compliance policy guidances establishing a 1-year stabilization period, until November 27, 2024, for trading partners to implement and troubleshoot their electronic interoperable systems.
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FDA Issues Final Guidance on Real World Data and Evidence
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Last month, the FDA released its highly anticipated final guidance explaining how sponsors can utilize non-interventional studies with real world data and evidence to support regulatory decision-making for drugs and biologics.
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LDT Proposed Rule under White House Review
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Request for Comments
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Biocom California welcomes feedback from members on the following FDA draft guidance. Click here to submit comments via email.
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- Product stability and delivery device compatibility as a result of manufacturing changes.
- CMC changes requiring a new IND submission and reporting changes to an IND and BLA.
- Special considerations for tissue-engineered medical products.
This guidance may be of interest to sponsors of Investigational New Drug Applications (INDs) and applicants of Biologics License Applications (BLAs) for CGT products.
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Upcoming Regulatory and Reimbursement Events:
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Featured Members
Congratulations to Pfizer on the FDA approval of its vaccine, ABRYSVO, for use in pregnant women to prevent Respiratory Syncytial Virus (RSV).
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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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