Covid-19: The Regulatory Landscape of Medicinal and Medical Device Products for Human Use

Beninger, Paul

Abstract Against the backdrop of the Covid pandemic, the scientific and medical communities are working with all deliberate speed with state-of-the-art technologies to develop diagnostic and therapeutic products that can identify, treat and prevent SARS-CoV-2. This can only happen with the necessary statutes and regulations in place to facilitate the timely development, manufacturing, evaluation, and distribution of products that meet quality standards. The present regulatory landscape for medicinal and medical products for human use has been shaped by nearly twelve decades of statutory history that followed in reaction to disasters and tragedies. Five distinct, closely woven threads of developments have led to the regulatory infrastructure we have in place: (1) Regularized processes for routine development of medicinal and medical products for human use; (2) Expedited development processes to shorten time frames and expand patient populations; (3) Expanded Access mechanisms to make medicinal products available to patients prior to FDA approval; (4) Emergency Use Authorization during public health emergencies; and (5) the development of the generic drug and biosimilar biologics pathways to market. These mechanisms are being brought to bear to facilitate the defeat SARS-CoV-2.