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The Latest in Regulatory and Reimbursement
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The FDA released its contingency plan days before the government shutdown last week due to a lapse in federal funding. Before the shutdown, the agency published a trio of cell and gene therapy-related draft guidance documents, finalized a guidance on tools for remotely evaluating drug manufacturing facilities, and CDRH expanded its medical device recall communications program. CMS launched a new funding program focused on rural health challenges, and NIH established the nation’s first center aimed at developing standardized organoid-based new approach methodologies.
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What a Government Shutdown Means for the FDA
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While some user fee-funded work will continue, the agency cannot accept new drug, biologic or device applications. Inspections, pre-approval work and guidance development will be paused. See the FDA’s contingency plan here. |
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FDA Expands Early Alert Communications
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FDA Finalizes Remote Inspection Guidance
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The FDA issued new final guidance for NDA, BLA and ANDA applicants on how the agency intends to use alternative tools to remotely evaluate drug manufacturing facilities as part of the drug review process. |
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New CGT Draft Guidance Documents Published
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New Rural Health Transformation Program
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CMS launched its new $50B Rural Health Transformation Program which would provide states with funding over 5 years to address rural health challenges. November 5 is the deadline for states to apply for the program. |
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NIH Establishes First Organoid Development Center
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The NIH established the nation’s first Standardized Organoid Modeling Center focused on developing organoid-based new approach methodologies (NAMs) in order to reduce reliance on animal modeling. |
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Request for Comments
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Biocom California welcomes feedback from members on the following FDA draft guidance document. Click here to submit comments via email. |
► Development of Non-Opioid Analgesics for Chronic Pain
- Intended to assist sponsors in the development of non-opioid analgesics for the treatment of chronic pain.
- Describes FDA’s current recommendations regarding phase 3 trials for prescription non-opioid analgesic products.
- Responds to the statutory requirements of the SUPPORT Act, which directs FDA to issue or update existing guidance to help address challenges to developing non-opioid medical products.
This guidance may be of interest to drug developers.
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Upcoming Regulatory and Reimbursement Events:
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Featured Members
Congratulations to Eli Lilly and Company on receiving FDA approval for its estrogen receptor antagonist, Inluriyo, for the treatment of adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
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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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