FDA Drug Safety Rule Would Promote Preclinical Adverse Event Reports
This article was originally published in The Tan Sheet
Executive Summary
FDA's proposed definition of "suspected adverse drug reactions" would encourage more preclinical adverse event reporting
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Safety Reporting For OTCs Should Allow Targeted Risk Management – CHPA
FDA ought to consider targeted questionnaires for specific types of suspected adverse drug reactions (SADRs) rather than an "active query" approach when dealing with OTC products, CHPA says
Safety Reporting For OTCs Should Allow Targeted Risk Management – CHPA
FDA ought to consider targeted questionnaires for specific types of suspected adverse drug reactions (SADRs) rather than an "active query" approach when dealing with OTC products, CHPA says