CDER and ORA Enter Facilities/Inspections CoOps

FDA’s Center for Drug Evaluation and Research (CDER) and Office of Regulatory Affairs (ORA) have entered into a concept of operations (ConOps) agreement to integrate facility evaluations and inspections for human drugs. The agreement, Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations, outlines the responsibilities and workflow for pre-approval, post-approval, surveillance, and for-cause inspections at domestic and international facilities.

“ConOps will enable CDER and ORA to manage the growing complexity of the pharmaceutical landscape,” said CDER director Dr. Janet Woodcock and associate commissioner for regulatory affairs Melinda Plaisier, in a note to CDER staff.

The note goes on to highlight objectives of the agreement, including ensuring consistency, efficiency, and transparency in facility evaluations, inspections, and regulatory decision-making for marketing applications across FDA; increasing access to facility and regulatory decisional information; and meeting user fee commitments and improving the timelines for regulatory, advisory, and enforcement actions to protect public health and promote drug quality, safety, and effectiveness.

“It is essential that we mobilize to prepare for the commitments of the reauthorization of the human drug user fees,” said Woodcock and Plaisier.

The  Generic Drug User Fee Amendments II (GDUFA II), under the FDA Reauthorization Act (FDARA) signed into law on Aug. 18, 2017,  requires the agency to communicate final inspection classifications to facility owners within 90 days of an inspection starting October 2018, according to Woodcock and Plaisier. Additionally, the note states that the director and associate commissioner plan to adhere to this standard come fall 2017, and stress the importance of the program for honoring GDUFA II commitments.

Source: FDA