To mitigate pandemic disruption of component supply chains, the US FDA said it will downgrade some post-approval change categories for sterile drug container closure systems. The downgrade will cover drugs in shortage and those used to treat COVID-19.

FDA also should more fully explore using alternatives to on-site inspections the pandemic prevents it from conducting, said Mary Denigan-Macauley, director of GAO’s health care office.

Agency must plan to ensure that a growing backlog of surveillance inspections does not impede its ability to conduct inspections at high-risk sites, GAO official says.