FDA Bioequivalence of Complex Generic Products Fellowship

How To Apply

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A Complete Application Consists Of:

• An application
• Transcripts –  for detailed information about acceptable transcripts
• A current resume/CV, including academic history, employment history, relevant experiences, and publication list
• One educational or professional recommendation

All documents must be in English or include an official English translation.

If you have questions, send an email to ORISE.FDA.CDER. Please include the reference code for this opportunity in your email.

U.S. Food and Drug Administration (FDA)

FDA-CDER-

3/30/2027 3:00:00 PM Eastern Time Zone

Applications will be reviewed on a rolling-basis.

FDA Office and

Location:

Multiple research opportunities are 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) 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 work covers more than just medicines.

This research project is related to complex drug substances and complex formulations in the areas of parenteral, intrauterine, intravaginal, ophthalmic, otic, inhalation, nasal, topical, transdermal and transmucosal products to understand the formulations that have been approved under abbreviated new drug applications (ANDAs) and NDAs. The project will identify and develop in vitro, in vivo, or in silico techniques that may be capable of determining how various complexity factors can impact the performance of test products to their respective reference listed drug.

It will also identify potential scientific gaps in the application of novel technologies for characterizing complex generic products to support bioequivalence and product development.

Under the guidance of the mentor, the participant will gain a comprehensive understanding of the scientific and regulatory challenges that must be considered when establishing bioequivalence for complex generic topical, transdermal and transmucosal drug products. This will include combination drug-device products with device components that may themselves have degrees of complexity in design. In addition, the participant will gain knowledge in collaborating with cross-disciplinary teams to develop novel in vitro, in vivo, and/or in silico study designs for establishing bioequivalence with these products.

The mentor for this opportunity is Yan Wang (Yan.Wang
3.gov). If you have questions about the nature of the research, please contact the mentor.

March/April 2026. Start date is flexible and will depend on a variety of factors.

The appointment will initially be for one year, but may be renewed upon recommendation of FDA and is contingent on the availability of funds.

The appointment is full-time.

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

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…