When Worlds Collide: The Theory of Real-World Evidence Meets Reality
FDA Law Blog
MAY 13, 2024
Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). However, in our experience, there is a large gap between FDA’s lauding the value of RWE and practice. By Jeffrey N. Patients that use ESD undergo continuous 24/7 monitoring.
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