Drugs

Postmarketing Drug Surveillance Best Practices

FDA has posted a document entitled “Best Practices for FDA Staff in the Postmarketing Safety Surveillance of Human Drug and Biological Products” that outlines risk-based principles for the agency’s conduct of ongoing postmarketing safety surveillance for drug and biological products. The document, which was mandated by the Cures Act, includes what it describes as a “high-level overview of other drug safety surveillance data sources, tools, methods, and activities that extend beyond use of FDA’s adverse event reporting systems (described in section 3), as well as regulatory and other actions that can be taken in response to identified safety signals.”

When conducting surveillance, it says, agency reviewers should focus on information that suggests a safety signal or broadly describes safety concerns (i.e., important identified risk(s), important potential risk(s), and important missing information) for the product under evaluation. It also recommends that reviewers focus on the following safety information:

Important potential risks identified during the approval process and post-approval
Increases in the severity or frequency of reporting of a labeled event (i.e., adverse reaction)
Deaths, particularly in patients using the product for indications for which death would not be expected
Adverse events for which causal attribution to the product is biologically plausible, based on the product’s known pharmacological action or nonclinical toxicity studies
Reports of unlabeled and serious adverse events
Serious adverse events that are rare in the general population and associated with a high product-attributable risk (e.g.,Stevens-Johnson syndrome, Torsades de Pointes, or agranulocytosis)
Interactions with another drug or biological product, dietary supplement or food
Reports of reduced effectiveness
Medication errors caused by product name confusion or packaging
Off-label use, misuse, abuse, and other intentional uses
Serious risks that an approved risk evaluation and mitigation strategy is intended to mitigate

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome