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.
