MS in Regulatory Science Degree Details and Courses

This course introduces students to the regulatory frameworks governing the development, approval, and post-market surveillance of medical products including drugs, biologics, and medical devices. Students will explore the historical context of pharmaceutical regulation, the structure of the FDA, and the processes associated with product development. By examining regulatory submissions, case studies, and enforcement actions, students will gain the foundational knowledge and practical skills required for careers in regulatory affairs.

The Food, Drug, and Cosmetic Act governs the regulatory approval process for bringing a drug, biologic, medical device, food, or cosmetic to market. The class will discuss administrative procedures followed by the FDA. The course includes an overview of the drug, biologic, and medical device approval processes and the regulation of food and dietary supplements. Students then will be exposed to the enforcement activities of the FDA, including searches, seizure actions, injunctions, criminal prosecutions, and civil penalties authorized under the FD&C Act as well as other statutes, like the Public Health Service Act, which regulates the development and approval of biologics.

This integrative, case-based course will focus on applying knowledge gained from previous courses in the Master of Science in Regulatory Science program to actual cases from the FDA. For each case, students will assume the role of a regulatory specialist, an FDA reviewer or senior-level policy-maker, or other involved stakeholders, such as a consumer group or an advocacy group. Students will be expected to research, evaluate, and present scientifically and legally justifiable positions on case studies from the perspective of their assigned roles. Students will present their perspectives to the class and be asked to debate the issues with the other students from the perspective of their assigned roles. The major responsibility of the students in this course will be to make scientifically and legally defensible recommendations and to justify them through oral and written communication.

This introductory course is designed to provide students with a high-level understanding of the complex legal and regulatory requirements for foods. The United States will be the primary focus, but other country regulations will be discussed as contrasts. The history of food regulations will be presented along with the progression to current regulations. Discussions regarding the multitude of agencies overseeing regulations and how they interact will be covered. Regulatory impact on product development, supply chains and food safety culture with be among several topics to introduce foundations for effective communication and collaboration with stakeholders to ensure brand and consumer trust.

This course introduces students to the planning and work required to develop potential new drugs and biologics efficiently. Students gain a thorough appreciation of FDA and International Council for Harmonisation regulations and guidelines. Because the course emphasizes the importance of planning before the execution of any of the necessary steps, lectures use a “backward” approach, discussing the final analysis and report before developing protocols. Topics also include an overview of preclinical investigations, NDA/BLA format and content, clinical development plans, product and assay development, the IND, and trial design, implementation, and management. Prerequisites: 410.607 The Biotechnology Enterprise, or admission to one of the business/regulatory programs

This course explores the role of microorganisms in food systems and biotechnology, emphasizing both their beneficial and detrimental impacts. Students will study the diversity, physiology, and genetics of microorganisms relevant to food production, processing, and safety, while also examining their applications in modern biotechnology. Topics include microbial growth and control, food spoilage organisms, foodborne pathogens, and microbial ecology in food environments. Special emphasis will be given to the use of microbes in bioprocessing, fermentation, probiotics, bioengineered foods, and novel bioproducts, as well as the regulatory and safety frameworks governing their use. Case studies will highlight microbial applications in biotechnology industries, including production of enzymes, nutraceuticals, bioactive compounds, and functional foods. By the end of the course, students will gain a strong foundation in both classical food microbiology and its integration with biotechnology, enabling them to critically assess microbial roles in innovation, safety, and regulation of food and bioproducts.

Pharmaceutical/biotechnology product approval and marketing requires a good understanding of international regulatory affairs in order to successfully compete in today’s global marketplace. It is important for tomorrow’s leaders to understand and follow the regulatory differences to ensure optimum product development strategies, regulatory approvals, and designs for exports conforming to the foreign regulatory bodies. There are various product development strategies that industry is using to shorten the product development time by conducting preclinical programs outside the U.S., but the strategies require careful planning and interaction with the U.S. and foreign regulatory agencies. With the increased globalization of economy and exports, international regulations will have a bigger impact on the biotechnology business in the future. The course provides a review and analysis of the pharmaceutical/biotechnology product approval processes within the world’s major markets. The key strategies required in phases from preclinical product development to marketing approval of the products in Europe, Japan, and the U.S. will be compared and discussed. Students will explore the European Union regulations and their overall importance to international markets. The course will cover the salient features of common technical and regulatory documents required for submission and approval to the leading regulatory bodies in the world, general guidance documents, international harmonization, and the General Agreement on Tariffs and Trade.

Current Good Manufacturing Practice regulations are the minimum standards for the design, production, and distribution of drug products manufactured in the U.S. and internationally. In the U.S., they are codified at the federal level in the FD&C Act and the Code of Federal Regulations and are actively enforced by the FDA. These regulations, however, only begin to describe the practices used in the pharmaceutic and biotech industries. Additional sources of insight and guidance include the FDA’s guidance documents and training manuals, industry trade publications, international compendia, and standards-setting organizations. Students will learn the scope and history of the regulations, industry-standard implementation strategies and “best-practices” approaches, and the FDA’s current expectations. Students will also learn to apply practical solutions to the regulatory issues faced in the pharmaceutical and biotech industries today.

Good Food Production Practices are production and farm level approaches to ensure the safety of food for human consumption. Good food production and post-harvest guidelines are designed to reduce the risk of foodborne disease contamination. These good food production procedures can be tailored to any production system and are directed toward the primary sources of contamination: soil, water, hands, and surfaces. Good food production protocols were developed in response to the increase in the number of outbreaks of foodborne diseases resulting from contaminated food. Students will learn to develop good food production regulatory protocols using case studies.

This course provides a comprehensive introduction to medical devices and how they are regulated by the FDA. Topics that will be covered include an overview of the laws and regulations that govern medical devices, the FDA’s organizational structure and responsibilities for medical device regulation, and administrative and legal requirements for medical devices throughout the full product life cycle. Particular focus will be placed on the premarket review, post-market programs enforcement (e.g., Quality Systems Regulation, and FDA inspectional programs). Included will be discussions on the responsible offices and major program requirements and resources. Students will be given various case studies to examine the application of regulations and participate in a 510(k)/PMA workshop, mock inspectional audit, and mock enforcement action. Upon completion of this course, the student will have a working knowledge of the requirements and policies of FDA regulation of medical devices.

The global food supply relies on shared confidence amongst retailers, manufacturers, consumers, and governments, that food is sourced, produced, and distributed in a safe manner. Auditing of food safety programs, whether by 3rd parties, internal auditors, or regulators, is critical to maintaining industry credibility, efficiency, and safety. A brief overview of food law, a review of HACCP, and the principles and practices of auditing are included. Assessment of Food Defense, Foreign Supplier Verification, organic food certification, labeling, and recall plans is also covered. This course is designed to help strengthen the fundamentals of auditing skills to ensure that food safety standards are being adhered to on a consistent basis.

When a food is adulterated or misbranded in the US, it needs to be recalled by the producing firm. If an outbreak of foodborne illness occurs, regulators seek to determine the associated food so that it can be recalled. Both outbreaks and recalls rely on records of production and distribution, and food traceability is term used to describe the system that documents the history of a product, from its raw materials through to the final product. This course?covers the principles, regulations, and practices involved in tracing outbreaks of foodborne illness and executing recalls, with a focus on the role that traceability plays. Students will be equipped with the awareness, knowledge and skills necessary to evaluate and use traceability systems in order to protect public health during outbreak and recalls.

This course will cover basic design issues, conduct, and execution of clinical trials for drugs and biologics. Clinical trial design will be analyzed to better understand various clinical trial study designs along with concepts such as endpoint definition, control group selection, and eligibility criteria. Other areas of emphasis will include informed consent, safety monitoring, ICH Good Clinical Practice (GCP), basic statistical concepts, data collection and integrity, trial implementation and regulatory strategy. Various challenges and points to consider for conducting clinical trials in the 21st century will be highlighted along with a close look at regulations. There will be three hands-on projects which will include authoring an informed consent, designing a case report form, and creating a presentation on clinical trial strategy. Prerequisites: 410.651 Clinical Development of Drugs and Biologics (recommended).

This course provides an overview of the biological processes and laboratory techniques utilized for the discovery, development, and evaluation of therapeutic drugs. Students investigate drug development processes, such as gene cloning, culture scale-up, downstream processing, and product purification. Emphasis is placed on the theory and application of laboratory methods used in drug development, such as recombinant DNA techniques, antibody technology, protein purification, immunoassays, high-throughput drug screening, chromatography, electrophoresis cell receptor characterization, pharmacokinetics, drug toxicity testing and evaluation of therapeutic drugs, diagnostics, and vaccines. Prerequisites: 410.607 The Biotechnology Enterprise, or admission to one of the business/regulatory programs

This course provides a comprehensive overview of the U.S. Food and Drug Administration’s (FDA’s) regulation of the research and development, and marketing of new drugs, biologics, and medical devices. The regulatory requirements for investigational (Investigational New Drug (IND) and Investigational Device Exemption (IDE)) and premarket approval (New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Biologics License Application (BLA), premarket notification (510(k)), Premarket Approval (PMA)) applications will be addressed. The content and format requirements for the preparation, submission, and maintenance of these applications will be covered.

As artificial intelligence (AI) and software play an increasingly critical role in biomedical science and healthcare, understanding their regulatory landscape is essential. This course explores how the U.S. government, particularly the FDA and other regulatory agencies, oversees AI/ML-based technologies, digital health solutions, and software used in biomedical applications. Topics include the regulation of software as a medical device (SaMD), model-informed drug discovery (MIDD), AI-driven diagnostics and imaging, telehealth platforms, electronic health records, clinical trial technologies, and laboratory information management systems. Additionally, the course examines HIPAA privacy rules, cybersecurity considerations, real-world evidence applications, and evolving policies for AI in regulatory decision-making.

This course provides an in-depth exploration of the principles and applications of toxicology as they relate to food, biotechnology, and bioproducts. Students will examine the biochemical and molecular mechanisms of toxic agents, natural and synthetic toxins, food contaminants, and processing byproducts. Special emphasis will be placed on emerging biotechnologies, such as genetically modified organisms (GMOs), novel proteins, bioengineered foods, and nutraceuticals. The course integrates toxicological science with food safety and regulatory frameworks, highlighting global standards (FDA, EFSA, Codex Alimentarius) and risk assessment methodologies used in evaluating food and biotech products. Topics will also cover toxicokinetics, dose-response relationships, biomarkers of exposure, carcinogenicity, and endocrine disruption, with case studies linking toxicological data to regulatory decision-making. By the end of the course, students will gain a strong foundation to critically evaluate toxicological risks in food and biotechnology, understand regulatory approval pathways, and apply safety principles in research, product development, and industry practice.

Risk analysis is composed of three separate but integrated elements, namely, risk assessment, risk management, and risk communication. Risk communication is an interactive process of exchange of information and opinion on risk among risk assessors, risk managers, and other interested parties. Risk management is the process of weighing policy alternatives in light of the results of risk assessment and, if required, selecting and implementing appropriate control options, including regulatory measures. Students will learn how to integrate risk assessment, risk management, and risk communication using case studies.

This course addresses regulations that govern the manufacturing practices of dietary supplements, labeling compliance, ingredient safety, permitted claims and enforcement/litigation trends, adverse event reporting, the implications of FTC and FDA regulations, emerging issues and solutions, and relevant regulatory practices around the world. This course will enhance students’ abilities to manage the regulation of dietary supplements in human food and animal food/feed manufacturing sectors.

The Food Safety Regulation course is designed to provide students with in-depth knowledge and practical skills in ensuring the safety and quality of cannabis-infused food products. The course will cover regulatory compliance, food safety protocols, and the unique challenges associated with the cannabis industry, preparing students for leadership roles in this emerging field.

Given the costly drug development process and the limited resources of emerging biopharmaceutical companies, developing an early regulatory strategy - starting well before clinical trials are initiated - is extremely important for the success of a company. This course will discuss different regulatory strategies that several players of the U.S. biopharmaceutical industry have employed. Students will learn about interacting with regulatory agencies, the orphan drug development, accelerated approval, fast track, priority review, and other regulatory mechanisms, pharmacogenomics and biomarkers, adaptive clinical trials, animal rule, generic drug development, and biosimilars. Using case studies, the impact of these regulatory strategies on drug development, and how these strategies have helped many biopharmaceutical companies will be discussed. At the end of this course, students will better understand federal regulations and the aspects involved in developing efficient regulatory strategies.