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Fellowship in Regulatory Science Training (FiRST)

Fellowship background photo

Why FiRST?

Regulatory science is evolving at an unprecedented pace, requiring a workforce ready to evaluate the latest innovations in health and consumer products using regulatory approaches grounded in contemporary science.

The Reagan-Udall Foundation for the FDA’s Fellowship in Regulatory Science Training (FiRST) program works directly with the FDA to prepare the next generation of regulatory experts.

Working side-by-side with senior scientists at FDA, FiRST Fellows will be placed across FDA with opportunities to conduct cutting-edge regulatory science and develop new techniques and methods for evaluating regulated products.

Scroll down to read more about the program.

Overview of FiRST Fellowship

FiRST prepares post-doctoral scientists, health professionals, and engineers to excel in the complex, technical demands of the future. Focused on meeting the broad needs of the 21st Century workforce, FiRST Fellows will tackle research questions that will help modernize review and evaluation processes at FDA, enable companies to accelerate product development, inform academic research, and infuse regulatory science and policy considerations into other government agencies, think tanks, and nonprofit organizations.

FiRST focuses on the critical intersection of regulation and science, immersing Fellows in safety evaluation at FDA. During this time, each Fellow will be assigned a mentor to engage in a research project and training curriculum. Fellows are expected to be at the FDA for at least two years and in an optional third year, the Fellow may pursue a Master’s degree in public health or work with an industry partner.

Get Involved

To learn how you can get involved as a FiRST partner, sponsor, or Fellow, email fellowship@reaganudall.org.

A Pipeline of Experts

FiRST creates a pipeline of experts with unique experience by crafting opportunities for Fellows to:

  • Conduct laboratory research, such as developing laboratory methods or models
  • Learn about agency planning, policy, and priorities, such as conducting research, drafting documents, and strategizing options
  • Engage in the development of regulations and legislative proposals, such as, pursuant to specific policy direction, conducting research
  • Understand regulatory review decisions through such activities as evaluating historical regulatory submissions to help devise options for clinical study requirements
  • Help develop communications projects, such as reviewing public and/or internal information, or analyzing communication or marketing activities
  • Support possible FDA regulatory actions and possible legal actions, such as reviewing historical inspection data and enforcement actions for a defined subset of a regulated industry

 

Sampling of Potential Research Areas (subject to availability)

Fecal Transplantation

Real-World Evidence

Regenerative Medicine

Bioinformatics

Genome Editing

Toxicology Risk Assessment

Nanotoxicology

Phage Therapy

Anti-Microbial Resistance

Translational Biomarker Discovery

Microbiome and Host Interactions

Patient-focused Drug Development

In Silico Modeling

Science of Patient Input

Evidence Generation

Opioids

Innovative Computational Modeling

Complex Generics/ Biosimilars/Biological Products/Combination Products 

Metagenomics and Whole Genome Sequencing of Foodborne Pathogens

Alternatives to Animal Testing