The FDA SBIA Event 2024, Back in Person.
This past week, the United States Food and Drug Administration(FDA) hosted its annual Regulatory Education for Industry (REdI) Annual Conference. The event had three offices of the FDA presenting under three unique tracks, drugs, devices, and biologics: Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), Center for Biologics Evaluation and Research (CBER). This was the first time since COVID-19 the event was in person!
Overall, the event is hosted under CDER, which both other offices also join. It was a public, open invite, no-cost event aimed at smaller businesses that must interact with the FDA in some way. Noted throughout the event was the Division of Industry and Consumer Education (DICE) program, which is a great place for anyone to contact the FDA if they need guidance or assistance in any process with the office.
Regulator lectures ranged, but from the highest level, themes of innovation and harmonization were clear. Additionally, clarity was provided around submission types by offices. For example, the CDRH noted the DeNovo program revamps in the last several years, helping to provide efficiency and an overall better approval process.
Another common theme pertained to our centralized healthcare system and the way drug delivery, clinical programs, and other aspects of our interaction with medicine centers around hospitals and care centers. This is notable as the majority of the United States healthcare system centers around large brick-and-mortar facilities. A great example given by Karen Jackler, MPH, in her CBER Patient Engagement lecture, highlighted the importance of patient-centric approaches in clinical trials. Families of children with degenerative diseases often face significant challenges in transporting their children. Blood draws are frequent and required for many clinical trials, so imagine the strain on a family when they can only be conducted at the facility administering the clinical trial, over two hours away. Jackler emphasized that these procedures should be flexible, allowing for blood draws to be done at local facilities to accommodate the patients’ needs better. Taking a more patient-centric approach, allowing for flexibility in the clinical trial, could not only reduce participant burden but maintain an effective and feedback-focused clinical trial.
Beyond this singular example, my experience with the event was both positive and impactful. I gained a far more comprehensive understanding of what the FDA does as a whole and how the office is broken down by sub-offices and functions. I have linked the conference resources here and broken down a further outline of the events, slides, and categories here.
