USA – 2020 Drug Safety: CDER spotlights COVID-19 activities, nitrosamine contamination

COVID-19 was a big safety focus in 2020 for the US Food and Drug Administration (FDA), from the evaluation of drugs for emergency use authorization (EUA) to surveillance for critical drug shortages and medical product supply chain disruptions.

The 2020 Drug Safety Priorities report from the FDA’s Center for Drug Evaluation and Research (CDER) chronicles a busy year in safety monitoring and enforcement, including COVID-related activities, nitrosamine impurities, and regulation of opioid reversal agents.  

“Although significant effort in 2020 was spent battling the COVID–19 pandemic, CDER continued to complete its critical work to ensure the safety of the medicines on which millions of patients rely,” Patrizia Cavazzoni, MD, CDER’s acting director, wrote in the report…