Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations

On June 6, 2017, the Center for Drug Evaluation and Research (CDER) and the Office of Regulatory Affairs (ORA) have entered into an unprecedented 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 the workflow for Pre-Approval, Post-Approval, Surveillance, and For-Cause Inspections at domestic and international facilities.
ConOps will enable CDER and ORA to more effectively manage the growing complexity of the pharmaceutical landscape and to meet new challenges by:

• Ensuring consistency, efficiency, and transparency in facility evaluations, inspections, and regulatory decision-making for marketing applications across FDA;
• Advancing strategic alignment across ORA and CDER functional units by creating clear roles and responsibilities;
• Improving FDA’s operational capacity by enhancing collaboration between various CDER and ORA offices;
• Enhancing the quality of and increasing access to facility and regulatory decisional information across FDA; 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.

Related Resources:

• Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations
• Questions and Answers on the Concept of Operations
• FDA Voice Blog:  New Steps to Strengthen FDA’s Inspection and Oversight of Drug Manufacturing