ParagonRx

Drug Companies Often Unprepared for REMS Evaluation, Expert Warns

Published in Medical Letter on the CDC and FDA, September 13th, 2009

While many pharmaceutical and biologics companies are getting accustomed to FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) programs for many new and old drugs, most are not adequately preparing for the equally mandatory program evaluations beginning just 1-1/2 years after each REMS is put into effect.

That warning has been issued by risk management expert Jeffrey Fetterman, CEO of ParagonRx, a Delaware-based company specializing in optimal medication use, in a blog posted to the company's Website - www.paragonrx.com.

"FDA requires an assessment of REMS performance at intervals no less frequently than 18 months, 3 years and 7 years post...

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Source: Medical Letter on the CDC and FDA (2009-09-13)

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