FDA Over the Counter (OTC) Drug Product Regulatory Analysis of Monograph

About the Research Project

This ORISE research project will analyze published literature to consider the human microbiome (e.g., oral, skin, etc.) and its role in the development of diseases relevant to over-the-counter drugs. The project's goal is to provide scientific updates for testing methodologies used to assess the effectiveness of nonprescription drug products. Current FDA guidance for certain categories of over-the-counter drug products relies on older test methods that may not fully reflect contemporary understanding of the microbial landscape and its complexity. Under the guidance of assigned mentor(s), you will conduct a comprehensive literature review of human microbiome dynamics and microbial community-mediated pathogenesis in disease states relevant to nonprescription drug products. You will also examine whether existing OTC monograph test methods reflect current basic and applied science and recommend new methodologies as needed.

Specific Activities

• Conducting a systematic review of peer-reviewed literature from 2003 to present using databases such as PubMed, Embase, and Web of Science.
• Reviewing existing FDA monographs, guidance documents, and regulatory precedents pertaining to OTC drug product monograph testing requirements.

Learning Objectives

• Regulatory science methods: Understanding how final formulation test methods informs OTC drug monographs and labeling.
• Scientific writing and data analysis/synthesis: Developing a peer-reviewed manuscript for a regulatory science journal with data tables and visual infographics.
• Participate in internal scientific seminars, regulatory training courses, and FDA scientific poster sessions to strengthen your communication abilities.

Mentor

The mentor for this opportunity is Michelle Jackson (michelle.jackson@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentor.

Appointment Details

• Start Date: 2026. Start date is flexible and will depend on a variety of factors.
• Length: The appointment will initially be for one year, but may be renewed upon recommendation of FDA and is contingent on the availability of funds.
• Level of Participation: Full-time, in-person at the FDA White Oak Campus in Silver Spring, Maryland.

Qualifications

• Currently pursuing or have received a doctoral degree in one of the relevant fields.
• U.S. citizenship required.
• Must have lived in the United States for at least 36 out of the past 60 months (36 months do not have to be consecutive).
• Must read and sign the FDA Education and Training Agreement within 30 days of start date.
• Must comply with FDA Ethics Requirements, including disclosure of financial interests in or relationships with Significantly Regulated Organizations.
• Completion of a successful background investigation by the Office of Personnel Management is required.
• Proof of health insurance is required for participation.