FDA Updates Guidance On Adverse Reporting During a Pandemic

by | May 21, 2020 | All Posts, COVID-19, FDA

The FDA made an update to their final guidance, “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic“. The guidance document now includes information for compounded drugs in Table 1:

Type of Product or Application Type of Report(s)/Statutory or Regulatory Timeframes(s) FDA Recommended Reporting During a Pandemic With High Employee Absenteeism
Prescription drug products marketed without an approved New Drug Application (NDA): drugs compounded or repackaged by outsourcing facilites 15-day Alert report, 15-day Alert – follow up/15 calendar days Submit

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