FDA Research Fellowship - Characterizing Use of to Effectiveness fo

How to Apply

Scroll to the bottom of this opportunity and click APPLY.

• Completed application
• Transcripts – see detailed information about acceptable transcripts
• Current resume/CV, including academic and 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. Include the reference code for this opportunity in your email.

U.S. Food and Drug Administration (FDA)

FDA-CDER-

8/28/2026 3:00:00 PM Eastern Time Zone

The Center for Drug Evaluation and Research (CDER), located at Silver Spring, Maryland.

You will join a project to conduct a systematic review of internal FDA approval documentation for new approvals, including clinical, epidemiological, and statistical reviews, advisory committee materials, and labeling. The project will extract key characteristics related to:

• Approval context and regulatory pathway
• Intended versus actual use of real‑world evidence (RWE) and rationale
• Role of RWE in the evidence base (substantial evidence of effectiveness/confirmatory evidence/other)
• Real‑world data (RWD) and RWE characteristics (data sources, study design, quality assessment, bias mitigation)
• FDA review findings (strengths, limitations, feedback, labeling)

With support from subject‑matter experts, you will develop at least ten training‑ready case studies across therapeutic areas focused on RWE in demonstrations of effectiveness for newly approved drugs and biologics. You will create a standardized case study template and an internal data repository to enable access to and dissemination of findings.

• Regulatory science landscape – familiarise with the role of RWE in regulatory science and emerging methodological developments that shape FDA’s approach
• Regulatory framework application – learn how FDA evaluates quality and reliability of RWE by studying application of regulatory science principles and FDA frameworks in past approvals
• Review and synthesis – conduct a comprehensive systematic review of internal FDA approval documentation to assess scope and frequency of RWE use
• Thematic and methodological analysis – identify cross‑cutting themes, methodological innovations, and recurring challenges in key characteristics such as approval context, regulatory pathway, data sources, study design, quality assessment and bias mitigation strategies
• Translation of findings into practice – develop at least ten training‑ready case studies and actionable best practices supporting consistent and appropriate use of rwd and rwe across cder for new approvals
• Cross‑Center collaboration – engage with subject‑matter experts and reviewers across other FDA Centers to adapt findings for wider regulatory decision‑making
• Scientific communication – strengthen ability to communicate key findings and recommendations through development of case study templates, internal data repository, peer‑reviewed publications, conference presentations, and strategic reports

Silvia Perez‑Vilar (silvia.perezvilar.gov) and Marie Bradley (marie.bradley.gov)

• Start Date:
  
  Flexible, 2026 (anticipated)
• Length:
  Initially one year, may be renewed upon recommendation and contingent on funds
• Participation Level: Full time
• Stipend:
  Monthly stipend commensurate with educational level and experience

Available to U.S. citizens, Lawful Permanent Residents, and foreign nationals. Non‑U.S. citizen applicants should refer to the Guidelines for Non‑U.S. Citizens Details page for valid immigration statuses.

• Proof of health insurance is required
• Completion of a successful background investigation by the Office of Personnel Management

Participation requires reporting any significantly regulated organization or prohibited investment fund financial interest. See FDA Ethics for Nonemployee Scientists for additional requirements.

ORISE participants must read and sign a FDA…