FDA awards $1.7 million to IU and other universities for quality management research

The U.S. Food and Drug Administration has awarded $1.7 million to five universities, including Indiana University, for a wide-ranging research project designed to help the agency better understand how to employ its quality management resources when inspecting drug companies’ manufacturing operations, thus benefiting consumers.

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KIDNEY HEALTH INITIATIVE LAUNCHES PROJECT TO MEASURE PATIENT PREFERENCES FOR NOVEL KIDNEY DEVICES

The US Food and Drug Administration (FDA) has awarded a contract to the Kidney Health Initiative (KHI) to study patient preferences for innovative renal replacement therapy (RRT) devices. The three-year project, “Building Capacity to Incorporate Patient Preferences into the Development of Innovative Alternatives to Renal Replacement Therapy” will capture patient preference and risk tolerance data from people with kidney failure to drive innovations in RRT.

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How Oncologists Can Ethically Navigate the “Right-to-Try” Drug Law

The 2018 federal Right to Try Act allows patients with a life-threatening illness to be treated with drugs that have not yet been approved by the Food and Drug Administration (FDA). Many in the oncology community say Right to Try strips away important regulatory protections and view the move as a risky step bound to create ethical dilemmas for physicians whose goal is to guide patients toward safe and appropriate treatment decisions. Oncology is one field at the forefront of requests for unapproved drugs. An interdisciplinary team of bioethicists, oncologists, and lawyers from Penn Medicine and other institutions penned a commentary published online this week in the Journal of Clinical Oncology to offer recommendations to help oncologists navigate this new “Right to Try” world, while maintaining their ethical obligations to patients.

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