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The Latest in Regulatory and Reimbursement
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Biocom submitted comments responding to a FDA draft guidance. CBER’s current director is slated to leave the FDA at the end of the month, the agency will hold a public meeting to discuss the Commissioner’s National Priority Voucher Pilot Program and the FDA has launched a new adverse event platform. MedPAC released its report to Congress and manufacturers of selected Medicare drugs have agreed to participate in the third cycle of the Medicare Drug Price Negotiation Program.
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Biocom Comments on FDA Draft Guidance
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Change of FDA CBER Leadership
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FDA CBER Director, Vinay Prasad, will be leaving the agency at the end of this month. The FDA expects to name a successor before his departure in the upcoming weeks. |
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Upcoming Public Meeting on FDA’s CNPV Pilot Program
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The FDA will hold a public meeting on the Commissioner’s National Priority Voucher (CNPV) Pilot Program. To date, the agency has awarded 18 CNPVs and approved five products in the pilot. |
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FDA Launches New Adverse Event Tool
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Last month, the FDA launched its new Adverse Event Monitoring System (AEMS) which displays adverse event reports for drugs, biologics, vaccines, cosmetics and animal food in a single dashboard. |
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MedPAC Releases Report on Medicare Payment Policy
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The Medicare Payment Advisory Commission (MedPAC) released its Report to the Congress with recommendations to update provider payment rates for fee-for-service care, trends, key issues in post-acute care and more. |
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Manufacturers Participating in Drug Price “Negotiations”
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Companies that manufacture the 15 selected drugs payable under Medicare Part B and/or covered under Medicare Part D have agreed to participate in the third cycle of the Medicare Drug Price Negotiation Program. |
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Request for Comments
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Biocom welcomes feedback from members on the following FDA draft guidance. Click here to submit comments via email. |
► General Considerations for the Use of New Approach Methodologies in Drug Development
- Provides a validation framework and general recommendations for using new approach methodologies (NAMs) in drug development.
- Intended to highlight scientific principles of study design and reporting that can be applied broadly and flexibly in the validation of NAMs.
- Does not address specific NAMs nor the use of NAMs in drug discovery; rather, it encourages the use of NAMs in regulatory submissions.
This guidance would be of interest to drug developers.
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Upcoming Regulatory and Reimbursement Events:
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Featured Members
Congratulations to Biocom members, Novo Nordisk and Eli Lilly and Company, on their recent FDA approvals of Wegovy HD and Foundayo, respectively.
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Biocom
For over 30 years, Biocom has advanced the life science industry with transformative resources that accelerate innovation. We help companies build meaningful connections and gain valuable insights through Conferences & Events, deliver access to Funding & Partnering opportunities, provide Group Purchasing solutions that drive efficiency and savings, champion Policy & Advocacy that protects and advances the innovation ecosystem, and strengthen talent pipelines through Workforce Development. Biocom is how the life science industry gets connected.
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