FDA Consistent Approach to Maximum Daily Dose Determinations Fellowship

Overview

*Applications will be reviewed on a rolling-basis.

FDA Office and Location: A research opportunity is available in the Office of Safety and Clinical Evaluation (OSCE), Office of Generic Drugs (OGD) at The Center for Drug Evaluation and Research (CDER), located at 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 work covers more than just medicines.

Research Project: The research project is related to the maximum daily dose (MDD) determinations of drug products. Multiple offices and divisions determine and rely on the MDD as part of their assessment of generic product applications.  Inconsistent MDDs can make it difficult to set appropriate impurity thresholds and to estimate maximum daily exposure to impurities or excipients in context of safety evaluation. The research project will aim to identify a consistent approach to determining MDD for drug products and create a database of MDD determinations by the Division of Clinical Review.  The project will also create a process for interdisciplinary communications when MDDs have been determined or updated.

Learning Objectives: Under the guidance of the mentor the participant will gain experience in the Abbreviated New Drug Application (ANDA) review process, understanding the regulatory construct under which generic drug applications are considered, and will enhance skills in working with databases to evaluate and compile clinical and pharmacological data.  The fellow will also enhance their critical communication skills by presenting the findings internally and externally to stakeholders, as appropriate.

Anticipated Appointment Start Date: 2024.  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.

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.
Qualifications
The qualified candidate should have received or be pursuing a master’s or doctoral degree in one of the related fields, or be currently pursuing with anticipated completion before the appointment start date. Degree must have been received within the past five years. Strong background in pharmacology with clinical experience is preferred.