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November 18, 2016

FDA CDER Identifies Nanotechnology as Area of Interest for Site Visit Training Program for OPQ Staff

Lynn L. Bergeson Carla N. Hutton

The Food and Drug Administration (FDA) published a Federal Register notice on November 16, 2016, announcing the 2017 Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program.  According to the notice, “[a] critical part of the commitment by CDER to make safe and effective high-quality drugs available to the American public is gaining an understanding of all aspects of drug development and a drug’s commercial life cycle, including the variety of drug manufacturing operations.”  The Site Visit Program is intended to offer experiential and firsthand learning opportunities that will provide OPQ staff with a better understanding of the pharmaceutical industry and its operations, as well as of the challenges that impact a drug’s development program and commercial life cycle.  CDER invites pharmaceutical companies interested in participating in the Program to submit a site visit proposal.  The notice states that while observation of all aspects of drug development and production would be beneficial to OPQ staff, OPQ identified a number of areas of interest to its staff, including emerging technologies such as nanotechnology.  Selection of potential facilities will be based on the priorities developed for OPQ staff training, the facility’s current regulatory status with FDA, and on consultation with the appropriate FDA district office.  Proposals are due January 17, 2017.