Impact Stories

To illustrate the unique value of CDER’s regulatory science investments we have developed a series of “impact stories” that describe recent  advances by our researchers and the impacts of these discoveries on drug development and the public health.

A Novel Stratum-Specific Trial Design Improves Statistical Power for Rare Diseases with Heterogenous Clinical Symptoms

September 22, 2026

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Proteomics-Based Biomarker Discovery: A Systematic Framework to Address Regulatory and Scientific Challenges Across Therapeutic Areas

September 22, 2026

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Comparative Clinical Studies for Assessing the Safety and Immunogenicity of Biosimilars

September 22, 2026

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CDER Investigators Address the Safety of CBD in a Randomized Trial

August 25, 2025

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Modern Intact NMR Approach Reveals Synchronized Microstructural Changes in Nanoemulsion Drug Formulations

August 4, 2025

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Streamlining analysis of ion channel in vitro assays data to support clinical cardiac safety decision-making

December 16, 2024

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Determining topical product bioequivalence with stimulated Raman scattering microscopy

December 14, 2024

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Opportunities for innovation in drug development for neurological conditions

July 12, 2024

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A novel method for rapid glycan profiling of therapeutic monoclonal antibodies

June 18, 2024

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How physicians interpret information about prescription drugs in scientific publications vs. promotional pieces

April 26, 2024

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Learning-enabled Natural Language Processing to Identify Directional Pharmacokinetic Drug-Drug Interactions

April 26, 2024

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Read our full collection of impact stories on drug development and public health.