USA – FDA publishes two guidances on collecting clinical outcomes data
The US Food and Drug Administration (FDA) has finalized two guidance documents in its series of guidances related to Patient-Focused Drug Development (PFDD). The documents outline the agency’s thinking on clinical outcome assessment (COA) data that can be used in premarket applications.
More information on Regulatory Focus Website.
Final guidance on COAs that use IRT
Final guidance on PRO data from cancer trials
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vroby (23 juillet 2024). USA – FDA publishes two guidances on collecting clinical outcomes data. ELSIBI. Consulté le 16 janvier 2025 à l’adresse https://doi.org/10.58079/122vy
