When Worlds Collide: The Theory of Real-World Evidence Meets Reality
FDA Law Blog: Biosimilars
MAY 13, 2024
Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). Further, FDA has stated that enabling advanced data analytics, including RWD, is one of the objectives incorporated in the FDA’s Information Technology Strategy for FY 2024-2027. By Jeffrey N.
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