FDA Guidance on Post-marketing Adverse Event Reporting During a Pandemic

The FDA has issued a formal guidance document providing recommendations to industry regarding post-marketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic.

FDA anticipates that during a pandemic, industry and FDA workforces may be reduced because of high employee absenteeism while reporting of adverse events related to the widespread use of medical products indicated for the treatment or prevention of the pathogen causing the pandemic may increase. The extent of these possible changes is unknown.

Some key points from the guidance:

  • Even during a pandemic, firms should continue to handle adverse event data per existing standard operating procedures and regulatory and statutory requirements, as much as possible.
  • Firms should have in place a Continuity of Operations Plan (COOP) to ensure that a firm’s operations continue during all stages of a pandemic, including instructions for reporting adverse events as well as a plan for the submission of any stored reports not submitted in the regulatory timeframes.
  • Firms that are unable to fulfill normal adverse event reporting requirements during a pandemic should maintain documentation of both of the following conditions:
    • Declaration of a pandemic (e.g., by the World Health Organization), including date of declaration of the pandemic and ending date of the pandemic
    • High absenteeism and/or other factors (e.g., an increase in adverse event reporting) that is/are preventing the firm from meeting normal adverse event reporting requirements
  • Following the resolution of the pandemic, firms should resume fulfilling all normal, pre-pandemic requirements, including the submission of any stored reports not submitted during standard regulatory timeframes during the pandemic.

Read the full guidance.

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