Design Studies to Support Global Drug Approval: FDA Draft Guidance

Drug developers could design multi-site international studies that produce data to support new drug approvals in multiple countries under FDA draft guidance issued Sept. 8.

The draft guidance, E17 General Principles for Planning and Design of Multi-Regional Clinical Trials, is the Food and Drug Administration’s move to adopt a guideline developed under the International Council for Harmonisation (ICH), which develops international standards for drug development.

The FDA and its counterparts are recognizing the impact of increasingly globalized drug development and the need to generate data that can be accepted across regions and countries as the primary source of evidence to ...