*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of Generic Drugs/ Office of Research and Standards (ORS), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) located in St. Louis, Missouri. 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 FDA, CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines.
Dysphagia affects approximately 15 million U.S. adults per year causing difficulty in swallowing tablets or capsules for therapeutic treatment. Some tablet or capsule products allow for co-administration via soft foods to improve compliance. Despite the benefits for dysphagic patients, the vast majority of tablet or capsule products are not formulated or assessed for co-administration via soft food. This study aims to evaluate how different soft food properties may impact product quality, which can inform development of reliable in vitro assessments to characterize co-administration of drug products with soft food.
Under the guidance of the mentor, the participant will learn the regulatory application of pharmaceutical product quality and will learn advanced pharmaceutical characterization techniques and methods.
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 initial appointment is for one year, but may be renewed upon recommendation of FDA contingent on the availability of funds. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. The appointment is full-time at FDA in the St. Louis, Missouri, area. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity (FDA-CDER-2021-0711) in your email.