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A new collaboration between CDER and ORA will more fully integrate drug review programs with facility evaluations and inspections, in an effort to streamline drug reviews while strengthening manufacturing oversight.
On Aug. 31, 2017, FDA Commissioner Scott Gottlieb, MD, outlined a new key step in strengthening the agency’s inspections and oversight of drug manufacturing. The step involves a collaboration between FDA’s Center for Drug Evaluation and Research (CDER) and the Office of Regulatory Affairs (ORA), which together will be implementing a new concept-of-operations agreement to more fully integrate drug review programs with facility evaluations and inspections for human drugs.
“This new collaboration is a model for how we’ll modernize other parts of our organization to better achieve our mission,” said Dr. Gottlieb in a statement.
The new agreement requires effort on behalf of the two offices to ensure alignment between FDA’s field professionals and the agency’s review staff. These efforts include the use of “Integrated Quality Assessment” teams. This team-based approach will align field and review staff to make closer consideration of all elements that create risk, including drug substance, drug product, manufacturing processes, and the state of the facilities that are regulated.
“This new framework between CDER and ORA, enshrined in the concept of operations that we are releasing [on Aug. 31, 2017], operationalizes these efforts. It outlines the responsibilities and workflow that CDER and ORA employees will follow in these pursuits. The new model will cover pre- and post-approval Inspections, surveillance inspections, and for-cause inspections at domestic and international drug manufacturing facilities that FDA oversees,” Dr. Gottlieb said in his statement.
FDA expects to meet its expanding commitments based on improved efficiency of inspections, and to also to fulfill its public health goals. One of the agency’s goals is meeting its commitments to improve the efficiency of its generic-drug program under the Generic Drug User Fee Amendments II (GDUFA II), in which the agency agreed to communicate final surveillance inspection classifications to facility owners within 90 days of an inspection.
“The new operating model will be a key element of meeting these promises. FDA will begin to operationalize this agreement this fall, with application to all human drugs, in order to more quickly meet this commitment,” said Dr. Gottlieb in his statement.
The concept of operations was developed by senior officials in CDER and ORA, with the active support of Janet Woodcock, director of CDER, and Melinda Plaisier, FDA’s associate commissioner for Regulatory Affairs. The agreement between CDER and ORA follows earlier efforts by FDA to remodel its oversight operations. FDA previously announced a restructuring of its field activities to direct focus and organization around the programs regulated by the agency, in comparison to the previous structure, which organized activities and resources around geographic regions.