2023 Drugs and Biologics Year in Review: Will FDA's 2023 Evolution Usher in Swift Resolutions for 2024?

The last year was an active one for the US Food and Drug Administration (FDA) with considerable, and even bullish, developments occurring across several areas, from drug and biologic development and manufacturing to labeling, advertising, and promotion guidance.

A common through line for FDA in 2023 was identifying inventive approaches for addressing existing regulatory issues, especially in light of new and novel technologies, taking into account lessons learned from COVID-19–era roadblocks and innovations. FDA makes clear through its policy developments that it is prepared to work with the life sciences industry to address the evolving drug development environment—whether that is achieved by creating efficiencies within the drug development and clinical trials space, implementing new technologies for manufacturing, finding new ways to manage risk, or permitting companies to communicate accurate and truthful information about their products.

While exactly how these new methods will be implemented by FDA and adopted by the industry, and what their impact will be, is yet to be seen, we expect to see a continuation of this pattern in 2024. Accordingly, companies should not shy away from engaging with FDA regarding their new or novel products or ways of meeting the applicable regulatory requirements as FDA is carving out space for increasing regulatory flexibility so long as the overarching requirements are met.

This report provides summaries of 44 FDA guidances and rulemakings issued in 2023 on premarket development, clinical trials, review standards, manufacturing, supply chain, promotion, and labeling considerations. Additionally, we provide insights into what some of these trends and rulemakings may mean for 2024 as their influence carries forward into the new year and beyond.