Frequently Asked Questions

What is regulatory science and how does it contribute to medical practice?

Regulatory science refers to the broad name of activities needed to develop and apply new methods, tools and standards to facilitate development of safe, effective and high quality medical products for at risk populations. For example, research aimed to incorporate methodologies that enable informed benefit-risk, science based decision making. Areas of special interest for medical countermeasure regulatory science include: (1) animal model development, (2) identification of biomarkers for safety and efficacy, (3) immune response including correlates of protection (4) assessment of product quality and (5) risk communication to improve health outcomes.

What role does the U.S. Food and Drug Administration play in response to the NIAID Public Health Emergency Medical Countermeasures Enterprise?

The Medical Countermeasures Initiative MCMi lays out a vision for a flexible, nimble system to produce medical countermeasures rapidly in the face of any attack or threat, known or unknown. The FDA has organized its MCMi around a three pillar action plan based on: (I) Enhanced MCMi review process and capacity, (II) Advance regulatory science for MCMi development and evaluation, (III) Modernize the legal, Regulatory and policy framework for effective Public Health Responses.

How is ORNcS involved in development and testing of MCMs to treat and/or prevent human infectious diseases recognized as medical threats to public health and safety?

Within ORNcS is an office of Regulatory and Scientific Affairs which houses professional staff including Study Directors who are Ph.D. scientists that conduct regulated vaccine or therapeutic studies in animal models to determine their efficacy to prevent or treat diseases for which MCMs are required. Often these diseases do not frequently occur in humans making it impossible to do human efficacy studies; therefore the disease in animals is used as a model to establish the efficacy and safety of the MCM. Data from these studies are audited by the Quality Assurance team to assure compliance and accuracy of study conduct. The combined data from multiple studies in animal models with a vaccine or therapeutic is then submitted in an Investigational New Drug (IND) application to the FDA for review to support licensure of the product for human use.