FDA Dose Optimization Over the Drug Lifecycle

*Applications will be reviewed on a rolling-basis.

FDA Office and Location: A research opportunity is available immediately with the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), 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. These efforts cover more than just medicines.

Research Project: Dose Optimization Over the Drug Lifecycle: Trends and Lessons from Postmarketing Dosage Changes in the Era of Targeted Therapies - Postmarketing dosage changes occur in approximately 20–25% of approved therapeutic products, driven by emerging safety signals, new subpopulation data, and expanded indications — yet systematic characterization of these changes across therapeutic areas and novel modalities remains limited. This project evaluates the patterns, drivers, and trends of postmarketing dosage changes to identify gaps in pre-approval dose optimization and inform more efficient, evidence-based dosing strategies that reduce downstream label revisions and support FDA's commitment to getting the right dose to the right patient at the time of approval.

Learning Objectives: Under the guidance of a mentor, you will have the opportunity to:

• Gain experience analyzing postmarketing dosage changes across therapeutic products and targeted therapies.
• Develop skills in evaluating trends, drivers, and patterns associated with dose optimization over the drug development lifecycle.
• Learn how emerging safety data, subpopulation analyses, and expanded indications influence regulatory dosage revisions.
• Gain exposure to evidence-based dosing strategies and approaches used to improve dose selection before product approval.
• Develop understanding of the role of regulatory science in optimizing patient-specific dosing and reducing postapproval label changes.

Mentor: The mentors for this opportunity are Anuradha Ramamoorthy  (Anuradha.Ramamoorthy@fda.hhs.gov) and Sarah Ridge (Sarah.Ridge@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentors.

Anticipated Appointment Start Date: September 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.

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, Lawful Permanent Residents (LPR), and foreign nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page of the program website for information about the valid immigration statuses that are acceptable for program participation.

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.