The FDA has updated its guidance for adverse event reporting in clinical trials conducted during the COVID-19 pandemic. For example, in trials of approved drugs being studied for COVID-19, companies must report spontaneous reports of serious adverse events related to the drug's off-label use in clinical practice to treat COVID-19.
FDA guidance targets adverse event reporting during trials
Sign up for ACG SmartBrief
Get the intelligence you need: news and information that is changing your industry today, hand-curated by our professional editors from thousands of sources and delivered straight to your inbox.