|
 FDA | CDER | Small Business and Industry Assistance
INDUSTRY NEWS
|
|
|
FDA’s Office of Pharmaceutical Quality releases a white paper on the economics of quality management incentives
The FDA's Office of Pharmaceutical Quality is pleased to announce the release of our new white paper: "Quality Management Initiatives in the Pharmaceutical Industry: An Economic Perspective" (July 2025).
This comprehensive analysis demonstrates that strategic investments in quality management initiatives deliver measurable returns for both companies and public health:
-
Economic Returns: Companies can realize significant cost savings through reduced defects, decreased waste, and improved operational efficiency. Even incremental investments in quality management can yield positive returns.
-
Public Health Benefits: Mature quality management practices help prevent drug shortages, strengthen supply chain reliability, and ensure consistent medication availability for patients. The paper quantifies the extensive costs of poor quality management - from direct manufacturing impacts to broader societal consequences.
-
Scalable Implementation: The economic model shows that quality management investments are not "all-or-nothing" — companies can implement stepwise approaches tailored to their specific context and resource levels.
The white paper includes real-world case studies, economic modeling, and analysis of costs across manufacturers, patients, healthcare systems, and society. It reinforces FDA's commitment to encouraging mature quality management practices that benefit both business outcomes and patient care.
We encourage you to review the full document and consider how these insights might inform the pharmaceutical industry’s quality management strategies.
|
|
|
The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry.
|
|
|
|
