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To learn more about Triangle CERSI, join our mailing list for future communications.

To learn more about Triangle CERSI, join our mailing list for future communications.

To learn more about Triangle CERSI, join our mailing list for future communications.

To learn more about Triangle CERSI, join our mailing list for future communications.

To learn more about Triangle CERSI, join our mailing list for future communications.

To learn more about Triangle CERSI, join our mailing list for future communications.

Regulatory Science

Regulatory Science and the FDA

Simply put, Regulatory Science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products.

The health and well-being of the American public depend on the FDA’s science-based regulatory decisions.

In 2020, FDA published a report of its focus areas as a way of communicating to its stakeholders about regulatory science needs and activities. This report was updated in 2022 with cross-cutting topics and four focus areas identified as needing continued investment in regulatory science research to facilitate development of innovative products, provide data and methods to inform regulatory decision-making, and improve guidance to sponsors. Cross-Cutting topics include: 

  • Minority Health and Health Equity 
  • Women’s Health 
  • Maternal Health 
  • Pediatric Health 
  • Oncology 
  • Rare Diseases 
  • One Health 
Four Focus Areas of Regulatory Science 
  • Public Health Preparedness and Response 
  • Increasing Choice and Competition through Innovation 
  • Unleashing the Power of Data 
  • Empowering Patients and Consumers 

While these focus areas do not fully encompass all FDA areas of regulatory science, they do represent areas where FDA is hoping to fund research through the CERSI mechanism. 

What is Regulatory Affairs? How is it related to Regulatory Science? 

Regulatory affairs and regulatory science are two related but distinct fields. Regulatory affairs involve the practice and oversight of regulatory processes, compliance, and submissions required for the approval, marketing, and post-market surveillance of products regulated by government agencies. Often, regulatory affairs professionals work in the pharmaceutical, biotechnology, medical device, food, cosmetics, or chemicals industries preparing and submitting regulatory documents, communicating with regulatory agencies, interpreting regulations, and ensuring compliance with applicable laws and guidelines. 

Regulatory Science focuses on the scientific underpinnings of regulatory decisions and policies. Regulatory scientists at FDA, within industry and across academic institutions conduct research to develop new methods, tools, or standards for evaluating the safety, efficacy, quality, and performance of regulated products to advance scientific knowledge in relevant areas. The field of regulatory science encompasses various disciplines, including pharmacology, toxicology, epidemiology, biostatistics, bioinformatics, and others, depending on the specific products or industries regulated. 

In summary, while regulatory affairs focuses on the practical aspects of navigating regulatory requirements and ensuring compliance, regulatory science is more concerned with the scientific basis for those regulations and the development of methodologies and standards used in regulatory decision-making. Both fields are essential for ensuring the safety, efficacy, and quality of regulated products and for facilitating their approval and marketing within regulatory frameworks. 
 

Interested in learning more?

Check out the 2022 update to the Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS)  report.

Did you know UNC offers a Masters Degree in Regulatory Science?

With an M.P.S. in Regulatory Science from UNC, you will be prepared to play a critical role in the public or private sector to ensure that pharmaceutical products are safe and effective for human use.