2024 was another year of major developments affecting companies regulated by the Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA). For example, a major agency reorganization fundamentally restructured how the FDA conducts its enforcement activities; major rules on good manufacturing practices for medical devices and the regulation of laboratory developed tests were finalized; and important rules affecting food labeling and medical product promotion through testimonials were finalized. In addition, the DEA undertook a process that would reform its approach to the regulation of marijuana.

Developments during 2024 related to FDA and DEA regulatory and enforcement activities will continue to reverberate throughout 2025 and beyond — particularly with the end of the Biden presidency and the beginning of the Trump administration. This white paper will cover the 10 most important FDA and DEA developments of 2024 — and our view of what’s to come in the near future.