FDA Releases Guidance on Drug Inspections, Supply Chain Changes During COVID-19
The FDA recently released a new guidance document responding to frequently asked questions about “regulatory and policy issues related to inspections, pending drug applications, and changes in manufacturing facilities for approved pharmaceutical products” during the COVID-19 pandemic. The guidance includes…
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information on the impact of COVID-19 and related travel restrictions on inspections of drug facilities, FDA actions to address imports, and changes to drug applications in response to supply chain disruptions due to the pandemic.