Education and Training Program for Outsourcing Facility Industry (UE5) Clinical Trials Not Allowed

The Food and Drug Administration's (FDA), Center for Drug Evaluation and Research (CDER)/Office of Compliance (OC)/Office of Compounding Quality and Compliance (OCQC), is announcing this Funding Opportunity Announcement (FOA) for a Cooperative Agreement. The goals of this Cooperative Agreement are to: continue the development of the Compounding Quality Center for Excellence Training Program, providing education and training for the Outsourcing Facility (OF) industry and other stakeholders with the capacity to expand into other program areas as directed; research and assess stakeholder training needs; and revise, develop and deliver and evaluate new and existing Current Good Manufacturing Practice (CGMP) training courses to stakeholders nationwide (Outsourcing Facility (OF), compounders, federal and state, regulators). This training and research program is intended to improve compounding quality to protect patients from unsafe, ineffective, and poor-quality drugs that may cause serious health consequences, impairment, harm, or death. Through a Congressional appropriation, FDA is directed to increase direct engagement and provide education and training to outsourcing facilities, compounders, federal and state regulators.