Health Affairs August 18, 2020
Anand Shah, Stephen Hahn

The COVID-19 pandemic has significantly impacted American society, with more than 160,000 deaths and 5 million cases as of August 2020. A novel pathogen like SARS-CoV-2 is uniquely challenging because of the real-time learning curve imposed on the medical and scientific communities to understand how the virus works and how best to detect infections, treat their effects, and contain further spread. To meet these challenges, the all-hazards preparedness framework of the Food and Drug Administration (FDA) equips the agency with specific authorities for use during emergency situations. Actions to date range from efforts to expedite access to timely medical products to initiatives to protect consumers from health fraud.

Over the past six months, the agency’s multi-faced pandemic response has included both policy and...

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2020-08-18T17:33:48-04:00