Getting Guidance from the Experts

Written By: Khang Nong, Thomas Adriaens, Kira Aldrich, Uyen Nguyen, and Mary Zhang, Third-Year Student Pharmacists

On April 22, our team had the opportunity to visit the U.S. Food and Drug Administration (FDA) to celebrate our first place win in the School of Pharmacy’s 2019 “America’s Got Regulatory Science Talent” Competition. We were able to meet with professionals from across the agency and discuss the winning proposal that landed us such a coveted opportunity: guidelines that could help the FDA draft official guidances and recommendations to establish ownership rights for data collected by wearable and implantable health care devices.

An Opportunity to Expand Our Professional Horizons

Our trip to the FDA was eye-opening. Because the Doctor of Pharmacy (PharmD) curriculum at the School of Pharmacy primarily focuses on the clinical aspects of pharmacy – such as interacting with patients and helping patients and providers manage medications – we don’t often have hands-on opportunities that allow us to explore the regulatory side of pharmacy. This experience allowed us to meet with different professionals from a variety of backgrounds, including scientists, pharmacists, and even cybersecurity experts. These professionals showed us how many different disciplines can work together to improve the safety of the drugs and medical devices that impact all aspects of many individuals’ daily lives.

In addition, because the visit was attended by “America’s Got Regulatory Science Talent” Competition winners from other universities in our region, we had the opportunity to meet more students who had goals similar to ours: to better understand the field of regulatory science. The presentations from the other students also provided an enlightening look at other areas within regulatory science, including some which our group wanted to learn more about, as well.

Everyone Has Knowledge to Bring to the Table

This experience helped us realize that, no matter what a person’s educational background might be, everyone can serve as both a student and a teacher. During our tour, we were able to meet a pharmacokinetics scientist who talked about his role at the FDA. Later in that same conversation, the scientist realized that one of the PhD students who was touring with us had actually taught him in one of his college classes. That interaction truly exemplifies the fluidity and flexibility of the roles at the FDA: there is always an opportunity for everyone to learn more and advance their professional capabilities.

The experts in wearable devices at the FDA also provided valuable insight and feedback about our winning proposal. It was exciting to see how our project could have real life implications in the very near future. The “America’s Got Regulatory Science Talent” Competition embodies the profession of pharmacy and it gives us as students an opportunity to test our skills outside of the curriculum. The role of pharmacists in health care is quickly evolving, and truly has the potential to influence health care and patient care on a larger scale.

To view a recording from our visit to the FDA, please visit An additional recap of the event is also available here on the FDA’s website.

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