BIO Submits Comments to FDA on "Draft Guidance for Industry on Medication Guides—Distribution Requirements and Inclusion of Medication Guides in Risk Evaluation and Mitigation Strategies"

BIO commends the FDA for taking this step to distinguish MedGuides approved under the Part 208 regulations from MedGuides required subject to a REMS. The Draft Guidance acknowledges there would be considerable efficiencies if MedGuides were implemented outside of the REMS framework. This change has the dual benefit of enhancing benefit/risk communication towards patients while reserving full-scale REMS implementation for elements to ETASU programs, so that all stakeholders in the healthcare delivery system can focus more resources on the most critical risk minimization activities. In the comments, BIO also asks for clarifications in support of the Draft Guidance.

Read the comments