Balancing Access and Innovation for Innovative Therapies – The Impacts of FDA and CMS Actions

Early 2024 | 2:00–3:30 PM ET | Live Webinar
Part of the FDLI Learning Series: Beyond FDA


How do the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) coordinate and work in parallel to ensure patient access to safe and effective treatments and encourage the advancement of innovation? How do their actions impact industry? There are a number of recent updates regarding FDA and CMS’s commitment to making sure that lowering prescription drug costs and improving access to innovative therapies are key priorities. Join panelists who will discuss these updates, including the revised guidance for the implementation of the new Medicare Drug Price Negotiation Program for 2026, FDA accelerated approval and CMS’s coverage of Alzheimer’s drugs, and CMS proposed guidance on the considerations in making national coverage determinations (NCD) utilizing the coverage with evidence development (CED) paradigm.


Speakers to be announced







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