USA – A compilation of FDA COVID-19-related guidelines

From the beginning of the coronavirus (COVID-19) pandemic, FDA actively provided guidance to members of the drug and biologic industries, including sponsors, investigators, pharmacies, and compounders. Now, as states begin to reopen, FDA appears to be looking toward the future, specifically providing guidance on prospectively addressing the impact of COVID-19 on clinical trials and compliance with current Good Manufacturing Practices (cGMPs). Below we provide brief summaries of key points from FDA’s drug and biologic COVID-19 guidance to date.

KEY TAKEAWAYS

  • Companies and entities within the drug and biologic industries should continue to track FDA’s COVID-19 related actions, as additional guidance and modifications to existing guidances are likely to be issued as reopening plans are implemented and stay-at-home orders are lifted…