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A REMS by any Other Name

 
• By Michael McCaughan

A new prescription drug for treatment of varicose veins clears FDA. The only dispute in the review: how to handle a remote but real risk of anaphylaxis. A REMS? Not this time…

Quick quiz: There's a new molecular entity pending at FDA, intended for a cosmetic use. There is a clear signal of a risk of anaphylactic reactions, most likely associated with off-label use at high doses. The review team is in agreement: there needs to be some form of communication plan and special monitoring to assure that physicians don't casually use higher doses.

Will the product have a Risk Evaluation & Mitigation Strategy as a condition of approval?

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