Bioanalytical inspections: organizational changes and regulatory perspectives.

Abstract

During January 2015, several offices within the Center for Drug Evaluation and Research (CDER) were re-organized to improve consistency of decision-making, and to streamline policy, procedures and communications. Some Divisions were elevated to Office status because of the increased number of personnel resulting from the passage of the Generic Drug User Fee Amendments of 2012 (GDUFA). The resources provided by the new user fees supported hiring more personnel to address the significantly increased workload and newly imposed timelines. The Division of Bioequivalence and GLP Compliance (DBGLPC), responsible for CDER’s Bioavailablity/Bioequivalence (BA/BE) Inspection Program and the Good Laboratory Practice (GLP) Inspection Program, became the Office of Study Integrity and Surveillance (OSIS). Additionally, OSIS became the newest suboffice under CDER’s Office of Translational Sciences. Previously, this group was in the Office of Scientific Investigations under CDER’s Office of Compliance. OSIS currently includes the Division of Generic Drug Bioequivalence Evaluation conducting and reviewing work under the BA/BE Inspection Program, and the Division of New Drug Bioequivalence Evaluation, which, in addition to the BA/BE program, also conducts and reviews inspections under the GLP Inspection Program. Concurrent with the reorganization, OSIS began to implement a surveillance approach to inspections in conjunction with the application-based inspections, conducted previously. This commentary provides an overview of changes in procedures within OSIS; it will also briefly discuss topics of interest that came up during the past year, including assays related to therapeutic biologics and immunogenicity testing.