CONTEXT: Opinion piece on where the author sees the FDA being focused through this next year.
IMPACT: Low
READ TIME: 2 mins
Quality Level Mean [1 – 10]: 6
1. “In 2020, the FDA recognized that a new approach was required to keep pace with the rapid evolution of science and technology driving drug development, and it released the report Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS) early in 2021 to identify and communicate areas requiring continued targeted investment.”
2. “Across the myriad of focus areas of the report’s major FDA Strategic Initiatives (Public Health Preparedness and Response, Increasing Choice and Competition through Innovation, Unleashing the Power of Data, and Empowering Patients and Consumers), five key elements deserve our attention.”
3. “MIPD encompasses model-informed drug development (MIDD), an approach that involves developing and applying exposure-based biological and statistical models derived from preclinical and clinical data sources to inform drug development or regulatory decision-making.”
4. “The FDA’s emphasis on advanced manufacturing — in particular, continuous manufacturing — is a major driver behind the resurgence of onshoring initiatives within the U.S.. Perhaps the most strategic initiative is the FDA’s focus on harnessing the power behind data, and a significant expanding area is digital health.”
5. “FDA’s Focus Areas of Regulatory Science capture an agency that is looking to provide meaningful regulatory insight on new and emerging approaches to drug development and governance.”
Source URL: https://www.clinicalleader.com/doc/fda-s-focus-areas-of-regulatory-science-trends-to-watch-0001