Douglas Crandell

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Latest Posts › Food and Drug Administration (FDA)

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FDA Publishes Case Studies and User Guide for Rare Disease Drug Developers

Drug development programs face unique challenges in demonstrating the safety and effectiveness of drugs for treating rare diseases. The FDA’s Accelerating Rare disease Cures (ARC) Program started the Learning and Education to...more

3/27/2025 / Clinical Trials , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Life Sciences , Medical Research , New Guidance , Pharmaceutical Industry , Regulatory Requirements , Research and Development

FDA Provides Perspective on Goals and Challenges for Regulation of Artificial Intelligence in Medical Devices, Drug Design, and...

A recent article authored by Haider J. Warraich, MD; Troy Tazbaz; and Robert M. Califf, MD in the Journal of the American Medical Association, reviews the history of artificial intelligence (AI) regulation by the U.S. Food...more

11/27/2024 / 21st Century Cures Act , Artificial Intelligence , Clinical Trials , Drug Design , Food and Drug Administration (FDA) , Medical Devices , Prescription Drugs , Public Health , Regulatory Agenda , Software

FDA Approves Qalsody™ for Treatment of ALS

On April 25th, 2023, the U.S. Food and Drug Administration (FDA) approved QalsodyTM (tofersen) for the treatment of amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene...more

5/31/2023 / FDA Approval , Food and Drug Administration (FDA) , Life Sciences , Pharmaceutical Industry

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