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The Latest in Regulatory and Reimbursement
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Biocom California provided public comments at the FDA’s meeting on the reauthorization of PDUFA. The FDA announced a new CDER Director, published complete response letters of approved products, and held a joint workshop focused on reducing animal testing in drug development. CMS released its highly anticipated CY 2026 Physician Fee Schedule proposed rule and announced states participating in its Cell and Gene Therapy Access Model.
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Biocom California Presents at FDA Public Meeting
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Biocom California provided public comments at the FDA’s meeting on the reauthorization of the Prescription Drug User Fee Act (PDUFA). Our detailed comments were submitted to the docket.
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New FDA CDER Director Announced
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The FDA announced the appointment of Stanford faculty member and biotech executive, George Tidmarsh, M.D., Ph.D., as Director of the Center for Drug Evaluation and Research (CDER). |
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FDA Published CRLs of Approved Applications
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The FDA recently published more than 200 complete response letters (CRLs) from drug and biological product applications that were approved between 2020 and 2024. These CRLs are available at openFDA. |
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Reducing Animal Testing
FDA & NIH Workshop
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During a recent workshop, the NIH announced that it will no longer fund proposals that rely solely on animal testing. Instead, applicants are encouraged to use alternative methods to assess a drug’s safety and efficacy. |
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CY 2026 Physician Fee Schedule Proposed Rule
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States Now Participating in CMS’s CGT Access Model
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Request for Comments
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Biocom California welcomes feedback from members on the following topic. Click here to submit comments via email. |
► Reauthorization of the Medical Device User Fee Amendments (MDUFA), Request for Comments
FDA is interested in responses to the following questions:
- What is your assessment of the overall performance of MDUFA V thus far?
- What current features of MDUFA should be reduced or discontinued to ensure the continued efficiency and effectiveness of the medical device review process?
- What new features should FDA consider adding to the program to enhance the efficiency and effectiveness of the medical devices review process?
- What changes, if any, could be made to the current fee structures and amounts to better advance the goals of the agreement, including facilitating product development and timely access for consumers?
This guidance may be of interest to device manufacturers.
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Upcoming Regulatory and Reimbursement Events:
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Biocom California
For over 30 years, Biocom California has helped move the life science industry forward with transformative resources that enable companies to make meaningful connections. 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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