Pharma and biotech companies to assess new FDA REMS guidance

Yesterday, the FDA issued very important draft guidance for pharmaceutical and biotechnology companies for formatting, assessing and modifying Risk Evaluation & Mitigation Strategies (REMS) to ensure the safe use of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.

Jeffrey Fetterman and Dr. Gary Slatko, both principals of ParagonRx, have helped many companies prepare REMS and related safety plans. They have previously co-authored two books on the topic and are now reviewing and interpreting this draft FDA guidance in a series of blog articles published at http://blog.paragonrx.com/.