Comment from EMD Serono a business of Merck KGaA, Darmstadt, Germany
AnonymousSupportBusiness
Summary: EMD Serono, the healthcare business of Merck KGaA, supports the draft guidance but proposes several specific refinements to improve clarity and practical implementation. They suggest narrowing the definition of "protocol" to avoid excessive reporting, clarifying the role of investigators, and recommending a separate, structured monitoring approach for protocol deviations related to safety events.
Comment letter submitted by EMD Serono a business of Merck KGaA, Darmstadt, Germany. Contact person Elizabeth Rosenkrands-Lange, Senior Director/ Head, US Regulatory & Scientific Policy