FDA Fiddles With Remote Drug Inspections While Pharma Burns, Bloomberg News

December 7, 2020By: Mark I. Schwartz Download PDF

Nearly a year into the pandemic, the Food and Drug Administration,
unlike its foreign counterparts, has yet to advance alternatives to on-site
facility inspections. Mark I. Schwartz, a director at Hyman, Phelps &
McNamara P.C. and former deputy director for the FDA’s Office of
Compliance and Biologics Quality, says the FDA must address this to
cure shortages of front-line drugs for treating Covid-19 patients and
other lifesaving medications.

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