Q1: What prompted development of the Concept of Operations (ConOps)?
A1: While working on Program Alignment, the Center for Drug Evaluation and Research (CDER) and the Office of Regulatory Affairs (ORA) identified an opportunity to further enhance collaboration beyond the specialization of field staff in the district offices. The ConOps between ORA and CDER outlines responsibilities and workflows that help streamline human drug facility evaluations, inspections, and communication.
The ConOps enables CDER and ORA to more effectively manage the growing complexity of the pharmaceutical manufacturing 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.
Q2: How does this effort relate to the recently announced Program Alignment initiative?
A2: The Program Alignment initiative implements a program-based management structure that aligns staff by FDA-regulated product. This enhances the effectiveness of communications, processes, and ORA’s ability to keep pace with scientific innovation and protect public health. This ConOps is complementary to the Program Alignment initiative by outlining how CDER and ORA will work in a vertically-integrated, programmatically-aligned environment regarding application reviews and inspections, and the compliance activities associated with them. This ConOps applies to Pre- and Post-Approval, Surveillance, and For-Cause Inspections of human drug facilities.
Q3: Are there any additional details available regarding changes in timelines and communications for the specific inspection types?
A3: CDER and ORA began to operationalize the ConOps in late 2017. One of the most anticipated results is meeting the Generic Drug User Fee Amendments II (GDUFA II) commitment to communicate Surveillance Inspection classifications to facility owners within 90 days of the end of an inspection and meeting GDUFA or Prescription Drug User Fee Act (PDUFA) application timeframes for Pre-Approval Inspections.
Q4: Can all facility owners expect final inspection classification communications within 90 days of inspection closing?
A4: CDER and ORA began issuing the 90-day decisional letters in late 2017 with a goal of 90 percent in this timeframe.
Q5: How does FDA communicate the final inspection classification?
A5: The ConOps created 90-day facility classification decisional letters to meet the GDUFA II commitment. FDA’s inspection classification is sent in a letter to the facility within 90 days from the end of an inspection. There are separate letters used depending on the facility classifications:
- no action indicated (NAI) (PDF - 42 KB)
- voluntary action indicated (VAI) ; or (PDF - 83 KB)
- official action indicated (OAI) (PDF - 66 KB)
The 90-day decisional letters explain what the classification means as well as how it may impact a company’s application approval.
Q6: Is the agency updating internal policies and procedural documents to reflect the ConOps?
A6: The ConOps agreement outlines responsibilities for CDER and ORA and the workflow for Pre-Approval, Post-Approval, Surveillance, and For-Cause Inspections and evaluations – for domestic and international facilities. CDER and ORA began developing processes to begin to operationalize these workflows in the fall of 2017. FDA has begun updating appropriate documents such as Compliance Programs (CPs, formerly known as Compliance Program Guidance Manuals), the Investigations Operations Manual (IOM), and the Regulatory Procedures Manual (RPM).
Q7: Will domestic and international facilities be evaluated differently?
A7: No, the ConOps will enhance FDA’s commitments to provide, among other things, risk-based parity and consistent processes for domestic and international facility evaluation and inspection.
Q8: Will the ConOps help address problems at manufacturing facilities that have impacted approval of drug applications?
A8: Manufacturers are responsible for ensuring that their products are manufactured to meet all of the quality standards and in accordance with the current good manufacturing practice (CGMP) regulations. The ConOps promotes transparency and communication between the agency and industry for facilities involved in manufacturing human drugs. The enhanced communication between FDA and facility owners may help them address problems more efficiently.
- Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations
- FY2019 FDA Concept of Operations Performance Public Report (9/9/2020) (PDF)
- FY2020 FDA Concept of Operations Performance Public Report (1/21/2022) (PDF)
- FY2021 FDA Concept of Operations Performance Public Report (6/3/2022) (PDF - 325 KB)
- FY2022 FDA Concept of Operations Performance Public Report (PDF - 334KB)