US FDA Eases Changes For Certain Sterile Injectable Container Closure Materials
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.
You may also be interested in...
Coronavirus Notebook: Remdesivir Supply Dwindles; US FDA Signs Another RWE Deal; Corning Gets BARDA Contract For Glass Vials
Dispatches from a world turned upside down also include changes in drug sample distribution guidelines and further reductions in the hours of FDA’s COVID hotline.
Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”
Questions about contamination control strategy raised as European Medicines Agency makes EU GMP Annex I revision a top priority in its 2021 work plan.