FDA Acknowledges Problems In Approach To Riskiest Drugs

Law360, New York (July 25, 2013, 3:32 PM EDT) -- The U.S. Food and Drug Administration on Thursday acknowledged confusion in its approach to risk-reduction strategies for potentially dangerous medicines and encountered criticism that patients aren’t assuredly being protected, marking an animated start to efforts at overhauling the safety measures.

Regulators are trying to harmonize so-called risk evaluation and mitigation strategies, which are meant to ensure proper use of potentially hazardous medications, and they kicked off a two-day workshop by recognizing that uneven standards have been applied since REMS debuted six years ago.

Adam Kroetsch, an...
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