ACG—FDA Visiting Fellowship Program

• Familiarize participants with the mission and history of the FDA.
• Develop an understanding of the technical language and science of drug development and key aspects of clinical trial design for registration purposes
• Understand the regulatory framework and benefit-risk assessment process
• Gain an understanding of the daily activities of the FDA that inform the advice provided to industry and academia to help facilitate drug development programs
• Interact with medical officers and scientists from various disciplines within and outside the Division of Gastroenterology

Fellows will complete a research project during this rotation. Fellows must also complete a report describing their experience and benefits gained from the fellowship program. This report 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 ad hoc members 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.

All current first– or second-year fellows are eligible to apply. Fellows should plan to finish this program during their fellowship (second or third year), and then present their experiences during the ACG Annual Meeting in October.

This is a one-month fellowship that will be scheduled to occur between February and May 2025. Participation will be completely virtual, therefore the candidate will be expected to remain at their home institution during the fellowship. As the ACG-FDA fellowship is a full-time activity, candidates are expected to focus solely on this fellowship during this one-month rotation. As such, the expectation is that candidates will be able to participate during a scheduled research block and will not be scheduled for clinical duties by their ACGME-accredited training program. The letter of support from the candidate’s program director should provide clear support for the candidate’s participation in this fellowship and should also describe the plan to ensure that the candidate can fully participate.

Selected applicants will receive an award of $1,000. Contingent on successful completion of the one-month virtual fellowship, an additional award of up to $1,000 will be provided by ACG for travel and related expenses to the ACG Annual Meeting including the FDA-Related Matters committee meeting. During the committee meeting, the fellows will be expected to present what they gained from their fellowship experience as well as their completed research project to the full committee.

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. 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.

Questions regarding this program should be addressed to Brad Conway at 301-263-9000 or bconway@gi.org.

Fellows will participate in the following activities*:

• Didactic and educational sessions- topics include:

  • Overview of FDA and Introduction to Regulatory Science

  • Fundamental Aspects of Pre-Clinical Development

  • Review and Evaluation of Clinical Trials Throughout the Drug Development Lifecycle

  • Regulatory Pathways to Approval

  • The Benefit/Risk Assessment

  • FDA’s Role in Post-Marketing Evaluation

  • Special Topics in Clinical Trials

• Division of Gastroenterology Medical Officer Educational Rounds

• One-on-one meetings with clinical reviewers and scientists from a variety of multidisciplinary teams and offices (as appropriate):

  • Pharmacology/Toxicology

  • Clinical Pharmacology

  • Product Quality

  • Regulatory Operations

  • Labeling Policy Team

  • Division of Clinical Outcome Assessment

  • Division of Pediatric and Maternal Health

  • Division of Pharmacovigilance, Office of Surveillance and Epidemiology

  • Office of Orphan Products Development or Rare Diseases Team

  • Office of Scientific Investigation

• Complete a report or independent project to be presented at the FDA prior to completion of the Visiting Fellowship Program and at an appropriate forum during the ACG Annual Meeting.
• Attend public advisory committee meeting(s) and/or workshops (if scheduled).

“I am grateful for this fellowship program put together by ACG and FDA; it transformed my understanding of what actually FDA does. What I most appreciated was meeting other fellows across the country who have done this fellowship too. Since participating, I have been able to build on what I learned to develop a fulfilling career in bringing new medical technology in gastroenterology to market – a career path that I did not know really existed at the time!”
– Eric Shah, MD, MBA, FACG and Chair of the ACG FDA Related Matters Committee

“The ACG-FDA fellowship was the highlight of my GI fellowship. It offered a unique opportunity to see regulatory medicine in action and gave me a better understanding of drug development and approval. I have been able to apply what I learned from this fellowship to my clinical practice and clinical research in celiac disease.”
– Amanda Cartee, MD, FACG and Vice Chair of the ACG FDA Related Matters Committee

“The ACG-FDA fellowship was one of the most meaningful experiences I had during my training. As a physician that cares for patients with pancreatic disorders, diseases which have few treatments, my experience at the FDA provided me with insight as to what is needed to safely develop therapies for patients. Since my fellowship, I have had the opportunity to partner with patients, national patient support groups, and industry in order to better define the disease state and help develop targeted therapies which can help prevent disease progression and importantly improve quality of life for our patients. None of this would have been possible without the knowledge I gained during this fellowship.”
– Yasmin G. Hernandez-Barco, MD

“As a visiting ORISE fellow at the Division of Gastroenterology and Inborn Error Products (DGIEP) at Center for Drug Evaluation and Research (CDER), I gained firsthand experience in the daily activities of the Food and Drug Administration (FDA) involving registration, approval and post-marketing activities of various drugs. I had the opportunity to interact with representatives from various disciplines within the DGIEP including the medical officers, clinical pharmacologists, basic scientists and statisticians learning each of their perspectives and inputs in the drug development/approval process. I also had an opportunity to spend time at the Gastroenterology and Renal Devices Branch of the Center for Devices and Radiological Health (CDRH). There I learned the registration and approval process for various endoscopically placed devices by meeting various bio-medical engineers and medical consultants. I also interacted with a medical officer at the Center for Biologics Evaluation and Research (CBER) to learn the registration process of several investigational biological molecules. Overall, my experience at the FDA was truly fulfilling and facilitated my academic career development. I thank the ACG for developing this fellowship program and am proud to be the first recipient of this award.”
– Deepinder Goyal, MD