Regulatory Guidance

At the beginning of April 2023, the FDA published a draft of the fourth in a series of Guidance Documents entitled “Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments (COA) Into Endpoints For Regulatory Decision-Making”.  Once finalized these four documents will be combined and will replace the 2009 Guidance, “Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims”.  Part 3, which was released in draft in June 2022, provides advice around the development and validation of new COA (including the modification of existing COA).

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Medable CEO Michelle Longmire and Dr. David Fajgenbaum, co-founder of EveryCure, join Pharmaceutical Executive podcast to talk about their partnership adn navigating the regulatory landscape.  

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See what key trends and takeaways were at the 2023 JPM conference and how they'll drive the landscape of pharma.

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