Zdrowie i gospodarka · 18/11/2011

FDA Releases Guidance on Medication Guide Distribution Requirements and REMS Inclusion

The Food and Drug Administration (FDA) has published a guidance document addressing the distribution of Medication Guides for prescription drugs and biological products, as well as their inclusion in Risk Evaluation and Mitigation Strategies (REMS). The guidance aims to clarify FDA's enforcement discretion and requirements for Medication Guides in REMS.