FDA / CDER’s DSPB / office of Biotechnology / office of New Drug Quality Assessment / Critical Path Institute / Duke Clinical Research Institute / Center for Drug Evaluation and Research / office of Generic Drugs / Data Standards Program Board / Food and Drug Administration / ISO IDMP / Standards Development Organization / Organization for Standardization / Coalition for the Advancement of Standards and Therapies / CDER DSPB / office of Regulatory Policy / /