Lexology April 28, 2022
The COVID-19 crisis called for governmental responses of unprecedented scale, scope, and speed. COVID-19 stressed not only medical infrastructure, supply chains, and financial systems, but also the very regulatory apparatus the government must use to react. Regulatory agencies had to respond nimbly, with at times imperfect information and in unfamiliar territory beyond their core mission areas. Agencies accustomed to following deliberate administrative processes had to act and make significant policy decisions in mere days, balancing important competing concerns, such as keeping critical infrastructure operating while curtailing virus transmission, requiring cross-agency partnership. And regulatory agencies found great value in collaboration with industry and other stakeholders.
Flexible regulatory approaches emerged by necessity to allow FDA...
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