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The Latest in Regulatory and Reimbursement
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The FDA released its highly anticipated proposed rule on laboratory-developed tests and launched a pilot program to support the development of rare disease therapeutics. The agency formed a new Digital Health Advisory Committee and jointly issued guiding principles for Predetermined Change Control Plans for machine learning-enabled medical devices. CMS started patient-focused listening sessions as part of its Medicare Drug Price Negotiation Program and Medicare will now cover multiple PET imaging scans for Alzheimer’s patients.
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FDA Releases New Proposed Rule for Lab Developed Tests
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The agency’s proposed rule would make explicit that in vitro diagnostic products are medical devices and would phase out enforcement discretion for Laboratory Developed Tests (LDTs) over a 4-year period. |
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START Pilot Launched for Rare Disease Therapies
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New FDA Digital Health Advisory Committee
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The newly formed Digital Health Advisory Committee will advise the Commissioner on issues and policies related to digital health technologies and the FDA is currently seeking subject matter experts to join the committee. Nominations are due to the FDA by December 11. |
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USA, Canada, and UK Jointly Issue PCCP Guiding Principles
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CMS Holds Patient-Focused Listening Sessions
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Starting October 30, CMS has been hosting a series of patient-focused listening sessions for stakeholders to share relevant feedback on the first 10 drugs selected for “negotiation” as part of the Medicare Drug Price Negotiation Program. |
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CMS Removes Amyloid PET Scan NCD & CED
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CMS removed its National Coverage Determination (NCD) and coverage with evidence development (CED) for Positron Emission Tomography (PET) scans for beta-amyloid brain plaque and Medicare can now cover multiple scans for Alzheimer’s patients. |
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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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Featured Members
Invitae recently received a De Novo marketing authorization for its Common Hereditary Cancers Panel; a test which evaluates blood sample DNA to identify variants in 47 genes known to be associated with an elevated risk of developing certain types of cancer.
This month, the FDA approved Bristol-Myers Squibb’s nivolumab for the adjuvant treatment of completely resected Stage IIB/C melanoma in patients 12 years 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 {{{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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