FDA guides generic drugmakers on bioequivalence study disruptions amid COVID-19

FDA guides generic drugmakers on bioequivalence study disruptions amid COVID-19

Source: 
RAPS.org
snippet: 

The US Food and Drug Administration (FDA) on Tuesday gave advice to generic drugmakers on handling disruptions to bioequivalence studies needed to support abbreviated new drug application (ANDA) approval as a result of the coronavirus disease (COVID-19) pandemic.