*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of Pharmaceutical Quality/ Office of Pharmaceutical Manufacturing Assessment (OPMA), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland. 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.
Uniformity of dosage units (UDU) in a manufactured batch is one of the most critical quality attributes for solid oral dosage forms (IR, ER, tablets and capsules). FDA has not issued guidance to replace the withdrawn draft guidance since 2013. A large variety of BU/CU (blend uniformity/content uniformity) evaluation methodologies (e.g., sampling plans, testing protocols, acceptance criteria), mostly based on literature, can be found in submissions. Currently, OPMA assessors conduct BU/CU evaluations with uncertain levels of inconsistency which may bring confusion to the applications.
Under the guidance of the mentor, the participant will gain an understanding of the industry’s application of historical guidance/literature proposals in BU/CU of solid oral dosage forms; categorize various approaches/methods; identify potential risks to drug quality for each category, focusing on the inappropriate approaches/methods. The participant will also gain an understanding of how OPMA (OPQ) assessors review these proposals/methods; and check the consistency on risk assessment (initial and final) and typical BU/CU requirements for development, PPQ and commercial stages. The participant will be able to achieve consensus amongst OPMA assessors in risk assessment and decision-making on approvability of UDU testing proposals.
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 Silver Spring, Maryland, 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 in your email.