ParagonRx

Risk Evaluation and Mitigation Strategy Experts Continue Interpreting New FDA REMS Guidance

Recently, the FDA issued a very important draft guidance for pharmaceutical and biotechnology companies for formatting, assessing and modifying Risk Evaluation Mitigation Strategies (REMS) to ensure the safe use of pharmaceutical products. Experts are now reviewing and interpreting this draft FDA guidance in a series of blogs. - October 09, 2009