Unlocking Doors to Better Health. Annual Report +++

https://www.fda.gov/media/187053/download?attachment=&utm_medium=email&utm_source=govdelivery CDER’s Office of Clinical Pharmacology (OCP) in the Office of Translational Sciences has published its 2024 Annual Report, entitled “Unlocking Doors to Better Health.” Featured in this report is the newly established CDER Quantitative Medicine Center of Excellence, an alliance of several CDER Offices dedicated to maximizing synergies in innovative methods and technologies to advance drug development and improve public health. The report also highlights how OCP has continued to advance regulatory science in support of regulatory review, policy development, research, and public engagement. CDER investigators Address the Safety of Cannabidiol in a Randomized Trial https://www.fda.gov/drugs/regulatory-science-action/cder-investigators-address-safety-cbd-randomized-trial?utm_medium=email&utm_source=govdelivery Cannabidiol (CBD) is a nonpsychoactive cannabinoid that is present at relatively high levels in hemp, which is cannabis and derivatives of cannabis with extremely low concentrations of delta-9 tetrahydrocannabinol. In recent years, many unregulated hemp-derived cannabinoid products that contain CBD have become widely available to consumers, raising various safety concerns. A clinical trial conducted by CDER provides rigorous human safety data for cannabidiol at consumer-reported doses consistent with unregulated consumer products. By demonstrating that CBD use, at doses representative of those commonly reported by consumers of unregulated consumer products, can lead to liver enzyme elevations in healthy adults who are not taking any other medications, this study provides evidence that can be used to assess the safety of CBD products and inform discussions about appropriate safeguards. A Modern Intact NMR Approach for Characterizing Nanoemulsions https://www.fda.gov/drugs/regulatory-science-action/modern-intact-nmr-approach-reveals-synchronized-microstructural-changes-nanoemulsion-drug?utm_medium=email&utm_source=govdelivery Oil-in-water nanoemulsions are stabilized dispersions of nanoscale oil droplets that enhance the solubility and absorption of poorly water-soluble drugs by encapsulating them within the oil phase. The performance and stability of these drug delivery vehicles are sensitive to process and formulation parameters that must be carefully controlled to maintain desired drug properties. Due to the lack of non-invasive methods to characterize drug distribution in these emulsions, there are gaps in our understanding of how formulation and process parameters affect the final product, and this has hindered FDA’s ability to grant generic drug approvals. To address these gaps, CDER researchers have recently developed nuclear magnetic resonance (NMR) methods that eliminate the need for dilution when characterizing nanoemulsions. Based on data obtained in this study, intact NMR methods for characterization of nanoemulsions can now be recommended to generic drug sponsors. These sensitive and accurate analytical methods have the potential to save resources for the pharmaceutical industry, accelerate generic drug development, and enhance the quality assessment of these drugs, ultimately resulting in lower costs to the American public.