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

*Applications will be reviewed on a rolling-basis.

FDA Office and Location: A research opportunity is available at the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of New Drugs (OND) located in Silver Spring, Maryland. The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This effort covers more than just medicines.

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: You will receive multidisciplinary training in:

• 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.

Anticipated Appointment Start Date: 2026. Start date is flexible and will depend on a variety of factors.

Appointment 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: The appointment is full-time, in-person at the FDA White Oak Campus in Silver Spring Maryland.

Participant Stipend: The participant will receive a monthly stipend commensurate with educational level and experience. 

Citizenship Requirements: This opportunity is available to U.S. citizens only.

This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.

Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded at FDA.  OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years.

FDA Ethics Requirements

If an ORISE Fellow, to include their spouse and minor children, reports what is identified as a Significantly Regulated Organization (SRO) or prohibited investment fund financial interest in any amount, or a relationship with an SRO, except for spousal employment with an SRO, and the individual will not voluntarily divest the financial interest or terminate the relationship, then the individual is not placed at FDA. For additional requirements, see FDA Ethics for Nonemployee Scientists. 

FDA requires ORISE participants to read and sign their FDA Education and Training Agreement within 30 days of his/her start date, setting forth the conditions and expectations for his/her educational appointment at the agency.  This agreement covers such topics as the following:

• Non-employee nature of the ORISE appointment;
• Prohibition on ORISE Fellows performing inherently governmental functions;
• Obligation of ORISE Fellows to convey all necessary rights to the FDA regarding intellectual property conceived or first reduced to practice during their fellowship;
• The fact that research materials and laboratory notebooks are the property of the FDA;
• ORISE fellow’s obligation to protect and not to further disclose or use non-public information.