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Safety Reporting For OTCs Should Allow Targeted Risk Management – CHPA

This article was originally published in The Tan Sheet

Executive Summary

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

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FDA's proposed rule on suspected adverse events would generate excess reports without increasing the value of the surveillance, the Pharmaceutical Research & Manufacturers of America says

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