BioCentury
ARTICLE | Regulation

FDA warns of possible PDUFA delays due to COVID-19

May 28, 2020 11:18 PM UTC

FDA may not meet its goals for regulatory decisions during the COVID-19 pandemic, according to guidance published Tuesday.

“With many staff members working on COVID-19 activities, it is possible that we will not be able to sustain our current performance level in meeting goal dates indefinitely,” the agency said. “We anticipate that the New Drugs Program and the Biologics Program may need to allocate resources to focus on certain activities,” including coronavirus-related INDs, NDAs and BLAs...