Posted 24 February 2012
By Alexander Gaffney
The US Food and Drug Administration (FDA) released a final guidance on 24 February that deals with how it intends to enforce adverse event reporting (AER) requirements if-or when-an influenza pandemic occurs.
FDA notes that during a pandemic it anticipates that its resources-and those of some manufactures-will be deployed most prominently to deal with that particular public health issue. This is problematic, as the amount of products being used to combat influenza is likely to rise significantly, leaving a void in oversight for AERs.
The agency recommends that all manufacturers unable to submit AERs to FDA store the reports for later submission to FDA, along with documentation outlining why the manufacturer was unable to meet regulatory timeframes. FDA should be immediately alerted if a manufacturer is experiencing such difficulties.
The guidance applies to pharmaceuticals, biologics, medical devices and dietary supplements.
FDA - Guidance for Industry Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic
Federal Register Posting: Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic; Availability