The ACG-FDA Visiting Fellowship Program which gives a current first– or second-year fellow the opportunity to apply for a one-month rotation at the FDA.
The ACG-selected gastroenterology fellows will integrate into the daily activities of the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), Division of Gastroenterology and Inborn Error Products (DGIEP). Fellows will gain valuable experience in drug/medical device registration and approval process, and observe the interaction between the FDA, academia, and industry. Ancillary activities will include cross-FDA Center activities, such as interaction with colleagues in the Gastroenterology and Renal Devices Branch at the Center for Devices and Radiological Health (CDRH). Fellows will be expected to pursue an independent project aligned with their research interest and career development.
The College will provide a stipend for travel and daily living expenses.
If you have questions after reviewing the details below, please email bconway@gi.org.
Program Goals
- Develop an understanding of the interchange between industry and FDA as drug and device development programs are examined by regulators and modifications are negotiated in an ongoing dialogue.
- Interact with medical officers and scientists from various disciplines within and outside DGIEP.
- Develop an understanding of the technical language and science of drug and device development and clinical trial design for registration purposes.
- Familiarize participants with the mission and history of the FDA.
Fellow must complete a report describing experience and benefits gained from the fellowship experience. In lieu of the report the fellow may perform an independent project (such as research, manuscript, webinar, patient education brochure, etc.) on any aspect of their rotation. The report or project will be presented to the FDA prior to the completion of the fellowship and at an appropriate forum during the ACG Annual Meeting following the completion of the fellowship.
In addition, selected fellows will be invited to serve as an ad hoc member of the ACG FDA Related Matters Committee and participate in all teleconferences and Committee meetings.
Ultimately, fellows who have participated in this program will bring the knowledge gained to their own future work and interactions with professional colleagues to facilitate expeditious development of new drugs and/or devices.
Eligibility
Duration and Funding
The selected applicant will receive a stipend of $3,000, which includes airfare, living expenses and meals. Fellows are responsible for securing their lodging and meals but ACG staff will provide assistance. An additional $1,000 will be provided for travel and related expenses to the ACG Annual Meeting for their presentation.
Review and Selection Process
The ACG FDA Related Matters Committee will review applications and will select awardees. Awards made by the ACG FDA Related Matters Committee will be based upon the applicant’s credentials and endorsement from their program director.
Questions regarding this program should be addressed to Brad Conway at 301-263-9000 or bconway@gi.org.
Application
Draft Schedule
In addition to daily interactions with members from DGIEP, the Fellow will participate in the following activities:
- Didactic sessions (slides available and videotaped), selected lessons within the Modules from the New Reviewers Blended Learning Program, potentially including an introduction to FDA, CDER, and drug lifecycle, the pre-IND and IND review process, and post marketing activities. Selected lessons from the Introduction to Clinical Review Training Series (slides available and videotaped), potentially including an introduction to CMC/Pharm Tox/Clin Pharm, Pharm/Tox 101, Labeling Basics, Pediatric Drug Use and Development, Maternal Health and Drug Development, FDAAA-Related Safety Activities and the Role of the Medical Officer.
- Attend scheduled internal and industry meetings throughout the month.
- Attend monthly Medical Officer rounds, weekly divisional meetings, and weekly CDER scientific seminars.
- Participate in the planning and attend public advisory committee meeting(s) (if scheduled).
- One-on-one meetings with medical officers and scientists from the following disciplines (as appropriate):
- Clinical Outcome Assessments Staff
- Labeling Development Team
- Division of Pharmacovigilance, Office of Surveillance and Epidemiology
- Pharmacology/Toxicology
- Orphan Products/Rare Diseases
- Office of Scientific Investigation
- Gastroenterology and Renal Devices Branch, Center for Devices and Radiological Health (CDRH)
- Complete a report or independent project to be presented at the FDA prior to completion of fellowship and at an appropriate forum during the ACG Annual Meeting following completion of fellowship.
- A liaison from the FDA Related Matters Committee will be appointed to serve as mentor and interact with the fellow and his/her Preceptor during the fellowship.