A workforce skilled in regulatory science benefits more than just FDA: new approaches to drug development are critical across industry, academia and patient advocacy. The Reagan-Udall Fellowship for the FDA is a chance to shape the future. Join the FDA and its Foundation in preparing the next generation of regulatory scientists to meet the complex and specialized technical demands of the future. Scroll down this page to read about the benefits of underwriting a fellowship, an overview of the program and the eligibility requirements for future fellows.
Benefits of Underwriting a Fellowship
The Foundation Fellowship program is as innovative and customizable as the imaginations of its champions. Associations, companies or other partners are invited to share their commitment to advancement by underwriting a Fellowship. This commitment delivers a continuum of benefits:
- Shareable evidence of Corporate Social Responsibility and Philanthropy
- Contribution to a more nuanced, diverse scientific workforce of the future
- Role in the development of new regulatory pathways
- Recognition at Foundation’s annual public meeting in Washington, D.C.
- Tailored social media toolkit and inclusion in national press release
- Networking at Foundation’s annual Innovations in Regulatory Science Awards Gala
Call (202) 849-2075 or email us at firstname.lastname@example.org to ensure a future where the science of safety and efficacy is as advanced as the R&D it regulates.
Overview of Foundation Fellowship
Through the new Reagan-Udall Foundation Fellowship, FDA is committed to training fellows in the latest regulatory science and policy to foster a better understanding of FDA’s work in their post-fellowship employment and provide leadership in policy organizations, industry, academia, or the government.
The Foundation Fellowship will provide a unique research experience, with projects helping to address FDA’s regulatory challenges. Examples of possible research topics include epidemiology, biostatistics, bioinformatics, engineering, comparative effectiveness research, and clinical trial design. Innovative topics in the use of “big data” are encouraged.
Expectations of Foundation Fellows include:
- Participation in FDA mission related research project(s) that may be (1) a new project as proposed by the fellow funded by the Foundation and conducted under the guidance of an FDA mentor/scientist or (2) an FDA research project, funded by FDA and conducted under the guidance of an FDA mentor/scientist. Examples of such research include:
- Conducting laboratory regulatory science research, such as developing laboratory methods or models
- Conducting non-laboratory FDA-related research, such as analyses of data across regulatory submissions to address a regulatory science question.
- Participation in FDA meetings with sponsors, advisory committee members, and other stakeholders
- Attendance at FDA-sponsored training
- Reporting to the Reagan-Udall Foundation Fellowship Steering Committee on progress and achievements
The Foundation Fellowship presents a variety of valuable opportunities such as:
- Undertaking activities to support agency planning, policy, and priorities, such as conducting research, drafting documents, and strategizing options
- Providing assistance to support the development of regulations and legislative proposals
- Supporting regulatory review decisions, such as evaluating historical regulatory submissions to help devise options for clinical study requirements or learning and conducting preliminary evaluation of data in regulatory submissions and discussing preliminary analysis with a Mentor
- Helping to develop communications projects, such as reviewing public and/or internal information, or analyzing communication or marketing activities
- Supporting 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
- Contributing to regulatory science papers and/or publications, such as research reports and/or results
- Attending or presenting, in their individual capacity, at relevant conferences
Candidates may participate for up to three years experiential training at the FDA or a combination of FDA, accredited academic program and rotations in regulated industry or non-regulated industry such as technology and data companies. Some level of customization will be allowed depending on a candidate’s interests and experience.
Eligibility and Criteria
Though the Foundation is not currently accepting applicants, all future selections of candidates and their research projects will be made by a Reagan-Udall Foundation and FDA Fellowship Steering Committee.
Applicants must demonstrate expertise in a scientific area relevant to FDA’s regulatory science priorities through their academic studies, research, or prior experiences with governmental or nongovernmental agencies or in industry. Successful applicants will demonstrate that a Foundation Fellowship is a logical progression in their career path and that they will benefit from participation in the Foundation Fellowship.
Candidates will initially be post-Doctoral level (PhD, MD, DrPH, DO, PharmD, ScD, VMD or DVM) or in some cases may be Master’s level trained individuals in specialty fields such as engineering, medical informatics, or bioinformatics.
Applicants must be US citizens or hold permanent residence in the US through the end of their fellowship.
All applicants meeting the eligibility requirements may apply. Applicants who are selected must resign from their current employment as a condition of acceptance into the Foundation fellowship.
The fellow will most likely be located at one of the FDA facilities in the Washington DC metro area or across the country with the exception of external rotations or when undertaking academic coursework at one of our University sponsors.
Compensation will be determined based on the applicants’ background. Benefits will be provided.
Other Research Support
Fellows will be allocated a Foundation stipend each year to cover such expenses as a computer, lab and office supplies, training, and travel funds. All expenses will require prior approval by the Reagan-Udall Foundation for the FDA.
The fellow will be an employee of the Reagan-Udall Foundation for the FDA.
Ethics and Conflict of Interest
By virtue of reference to section 708 within section 770(k)(2)(B) of the Food, Drug and Cosmetic Act (FD&C Act), Foundation Fellows will be allowed to access information which is exempt from disclosure under the FDA laws, such as that typically contained in regulatory submissions including confidential commercial information and trade secrets.
Under Section 746(b) of the FD&C Act, Foundation Fellows are subject to conflict of interest and ethics rules in substance identical to FDA employees. The FDA will complete a background check before the fellowship commences.