FDA revamps adverse event reporting guidance for Covid-19
The FDA on Thursday revised its guidance on postmarket adverse event reporting for medical products and dietary supplements during a pandemic to apply the guidance to the ongoing coronavirus disease (Covid-19) pandemic.
The guidance, which applies to drugs, biologics, medical devices, combination products and supplements, details how FDA intends to prioritize adverse event reporting requirements during a pandemic.
The previous version of the guidance from 2012 specifically applied to influenza pandemics. FDA clarifies in the revised guidance that it applies to all pandemics, including COVID-19.
In the guidance, FDA acknowledges that companies and the agency itself may be hit with workforce shortages during a pandemic at the same time as adverse event reporting for products deployed for the pandemic may increase.
Accordingly, FDA says the aim of the guidance is to allow companies to “focus their limited resources” on submitting reports for products used against the pathogen causing the pandemic, as well as other specific reports identified in the guidance.
“During a pandemic, normal adverse event reporting processes should be maintained to the maximum extent possible,” FDA writes, noting that companies should develop and implement a continuity of operations plan (COOP) to follow in the event of employee absenteeism during a pandemic.
FDA clarifies that the guidance “is not intended to discourage adverse event reporting during a pandemic by firms that are able to continue reporting operations,” and does not apply to reporting obligations for products authorized for emergency use or investigational products.
Specifically, FDA says it does not intend to object to companies that are unable to submit adverse event reports to the agency within the required timeframes as a result of pandemic-related employee absenteeism, so long as they submit all delayed reports within six months of restoring their adverse event reporting processes “to their pre-pandemic state.”
FDA advises companies to keep records of any adverse events that have been stored and document when their reporting processes are restored.
FDA says there are some situations where it will expect companies to comply with normal reporting requirements during a pandemic, such as newly emerging product-related safety issues and product problems associated with adverse events.
The guidance also features a table detailing whether companies experiencing pandemic-related employee absenteeism should store or submit reports for various products based on the product type and use.
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RAPS: First published in Regulatory Focus™ by the Regulatory Affairs Professionals Society, the largest global organization of and for those involved with the regulation of healthcare products. Click here for more information.