FDA Updates Guidance On Adverse Reporting During a Pandemic
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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