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23 May 2024, 10:40 am by Peter S. Lubin and Patrick Austermuehle
A defense unique to a proposed class representative does not need to be a sure bet to defeat the adequacy required for class certification; it only needs to be arguable and substantial (Al Haj v. [read post]
22 May 2024, 7:07 pm by Kurt R. Karst
Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert —We recently blogged about the Center for Devices and Radiological Health’s (CDRH) reluctance to make full use of real-world data (RWD) and real-world evidence (RWE) to support marketing applications. [read post]