Drugs

FDA Division of Applied Regulatory Science Releases Annual Report

CDER Division of Applied Regulatory Science (DARS) has published its 2025 Annual Report, highlighting significant research advances, collaborative scientific efforts, and regulatory science initiatives aimed at improving public health and regulatory decision-making.

According to the report, DARS completed numerous applied research projects this year, advancing scientific understanding in several key areas:

Cannabidiol (CBD) Safety Research: A clinical study assessed the effects of consumer-level CBD doses on liver enzymes, uncovering elevated markers that underscore the need for further long-term safety investigation.
Opioid Interaction Studies: Ongoing research examined how certain psychoactive drugs interact with opioids, with implications for respiratory safety and regulatory strategies.
Advanced Laboratory Models: DARS scientists expanded the use of New Approach Methodologies (NAMs) — contemporary in vitro and computational models — to improve predictions of drug safety without relying solely on animal testing.

The report highlights advancements in tools that support regulatory review and risk assessment. For example, DARS helped enhance cardiac safety evaluation by incorporating human-derived cell models into regulatory review processes. New quantitative tools were also developed to assess carcinogenic risk from impurities in pharmaceuticals.

Additionally, the report outlines several new research directions primed for 2026 and beyond:

Drug-Drug Interaction Models: Studies will increasingly focus on how combinations of medications affect safety, particularly for cardiac effects.
Novel In Vitro Models for Breast Milk: Projects aim to model drug transfer into breast milk to better guide medication use in lactating women.
Cannabis and Driving Safety: Research will investigate how low-dose THC, especially when combined with alcohol, affects driving performance.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome