FDA Tracks

Make an immediate impact on public health during your fellowship!

The collaboration between Children’s National Hospital Infectious Diseases and the U.S. Food and Drug Administration (FDA) offers a unique opportunity combining top-notch clinical training with scholarly experience in the oversight and review of licensed and cutting-edge investigational drugs or vaccines.

As a reminder, clinical training is identical for all our fellowship tracks, with the tracks differing only in their research training focus.

What are the FDA fellowship tracks?

Two FDA fellowship track positions are available each year, one in the Center for Drug Evaluation and Research (CDER) and the other in the Center for Biologics Evaluation and Research (CBER).

The CDER fellowship track, housed in the Office of Antimicrobial Products (OAP), focuses on anti-infective products targeted against bacterial (including mycobacteria), viral, fungal and parasitic infections. The CBER fellowship track, housed in the Office of Vaccines Research and Review (OVRR), focuses on vaccines and live biotherapeutic products (drugs that are living organisms). In both the CDER and CBER tracks, fellowship scholarly activity may include evaluation of products being developed to address:

• Common infections in the U.S. (e.g. pneumonia, urinary tract infections, viral respiratory tract infections, HIV and tuberculosis)
• Healthcare associated infections (e.g., C. difficile and multidrug resistant organisms)
• Congenital infections (e.g., CMV, Group B Strep)
• Infections in the immunocompromised host
• Tropical infections (e.g., malaria, schistosomiasis and diarrheal diseases)
• Emerging infections (e.g. Ebola, Zika and pandemic influenza)
• Countermeasures for biothreat agents (e.g. anthrax and smallpox)

FDA fellowship activities may also focus on safety monitoring of licensed drugs or vaccines and considerations for changes in dose and regimen, combination regimens and new uses of licensed products.

The CDER and CBER tracks are filled independently through the Pediatric Subspecialties Match, though we encourage prospective fellows to apply to both tracks as they offer similar experiences.

What do FDA fellows do during their training?

Approximately 30 percent of the FDA track fellowship is devoted to clinical training and education at Children’s National. FDA fellows may also choose to pursue small research projects of interest with Children’s National faculty mentors. The remaining 70 percent of the FDA track fellowship is spent at the FDA campus in White Oak, Maryland, where fellows participate (under close mentorship and supervision as part of a larger review team) in the clinical review of drug or vaccine development and licensure. The major scholarly activity for the FDA fellowship tracks is the clinical review of at least one drug or vaccine licensure application, a comprehensive effort for which the final work product is typically longer and more detailed than a journal research article. Other fellowship activities at FDA include:

• Review of clinical trial protocols, drug development plans and study reports under the FDA Investigational New Drug (IND) process
• Meetings with academic and commercial developers to provide advice and feedback at various stages of drug and vaccine development
• Coursework in topics such as clinical trial design, biostatistics and epidemiology, benefit/risk analysis, microbiology, pharmacology and drug labeling
• Participation in local and national meetings and conferences, including interactions with other public health agencies (NIH, CDC, WHO)
• Smaller research projects that might only be accomplished with information available through FDA databases

FDA track fellows participate in the review process at all stages of drug or vaccine development and licensure, and routinely make contributions addressing highly complex questions of great importance and urgent public health needs.

FDA fellows may also choose to pursue small research projects of interest with Children’s National faculty mentors.

What do FDA fellows do after they graduate?

The FDA fellowship tracks at Children’s National prepare trainees to be highly competitive for positions in clinical practice, academia, industry or public health. Some graduates of the program have stayed on at FDA as full-time medical officers, while others have accepted academic appointments, joined international public health organizations, or continued their training with the CDC Epidemic Intelligence Service. Regardless of where their careers ultimately lead, FDA track fellows leave with a deep understanding of clinical trial design and analysis, strong training in critical thinking and communication skills and invaluable knowledge of U.S. drug or vaccine regulation and approval processes.