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The Food and Drug Administration (FDA) is announcing the following public workshop titled “Patient and Medical Professional Perspectives on the Return of Genetic Test Results.” The purpose of this workshop is to understand patient and provider perspectives on receiving genetic test results. The topic(s) to be discussed will focus on better defining the specific information…

By: Barbara D. Buch, M.D. There are few responsibilities at FDA more important than reviewing the design and outcomes of clinical trials. Understanding the science behind the trials — and the individuals included in them — helps us to ensure that the medical products we approve are safe and effective. Last year, FDA took important…

This public meeting will present FDA’s progress in implementing the “Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data,” required under Sec. 907 of the Food and Drug Administration Safety and Innovation Act (FDASIA). FDA will also be seeking feedback and recommendations from stakeholder groups: patient groups, consumer groups, regulated industry, academia…

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The Food and Drug Administration (FDA) is announcing the following public workshop entitled “Next Generation Sequencing-Based Oncology Panels.” The purpose of this workshop is to obtain feedback on analytical and clinical validation approaches for next generation sequencing (NGS)-based oncology panels. Comments and suggestions generated through this workshop will help guide the development of appropriate regulatory…

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