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Due Process And Administrative Hearings In The Time Of Covid-19: Help, I Need Somebody!, Leslie Birnbaum
Due Process And Administrative Hearings In The Time Of Covid-19: Help, I Need Somebody!, Leslie Birnbaum
Journal of the National Association of Administrative Law Judiciary
The COVID-19 pandemic has caused the reinvention of the administrative hearing process in a virtual or hybrid setting. Since March 2020, administrative forums have experienced continuances, backlogs, and the digital divide. The purpose of this paper is to examine the effects of COVID-19 on procedural due process and administrative hearings, and to address some of the problems and unanswered questions about the new normal. Part I presents background information about the virus and a brief history of pandemics. Part II examines past and present case law, and the NAALJ and National Conference of Administrative Law Judges' national survey. Part III …
The 21st Century Cures Act: A Patient's Miracle Or Demise?, Brittaney N. Edwards
The 21st Century Cures Act: A Patient's Miracle Or Demise?, Brittaney N. Edwards
Journal of the National Association of Administrative Law Judiciary
The 21st Century Cures Act is designed to expedite the FDA’s approval of pharmaceutical and medical device applications in order to increase patient access to innovative therapies. However, many experts claim that the Act’s Title III provisions promote evidentiary “‘shortcuts’” that eviscerate the safety and efficacy standards of the FDA approval process. For new drugs, Title III permits surrogate endpoints and real-world evidence in lieu of more rigorous scientific data. For new medical devices, Title III requires the FDA to exempt certain Class I and II devices from any kind of safety or efficacy evaluation. Moreover, Title III forces the …