1. Fair, Just and Compassionate: A Pilot for Making Allocation Decisions for Patients Requesting Experimental Drugs Outside of Clinical Trials

    Arthur L Caplan, J Russell Teagarden, Lisa Kearns, Alison S Bateman-House, Edith Mitchell, Thalia Arawi, Ross Upshur, Ilina Singh, Joanna Rozynska, Valerie Cwik, Sharon L Gardner First published July …Read More

  2. Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products – Content and Format: Guidance for Industry

    Office of Medical Policy in the Center for Drug Evaluation and Research (CDER) in cooperation with the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration First pub…Read More