Eric Furman, Ph.D.

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Latest Posts › Food and Drug Administration (FDA)

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Executive Order 14297 and the Global Drug Market: Policy, Pricing, and Uncertainty

On May 12, 2025, President Trump issued Executive Order 14297 targeting prescription drug prices in America. The stated purpose of this order is to combat high drug prices in the United States, bringing the prices Americans...more

5/30/2025 / Department of Health and Human Services (HHS) , Drug Pricing , Executive Orders , Food and Drug Administration (FDA) , Healthcare Reform , International Trade , Pharmaceutical Industry , Prescription Drugs , Regulatory Reform , Trump Administration

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

CDRH Announces Pilot Program to Improve Recall Communication

On November 21, 2024, the FDA’s Center for Devices and Radiological Health (CDRH) announced a pilot communications program for improving the timeliness for communicating high-risk recalls. The CDRH intends for the pilot...more

12/2/2024 / CDRH , Food and Drug Administration (FDA) , Pilot Programs , Product Recalls

Senate Seeks to Reduce Biosimilar Prices by “Pruning” “Patent Thickets”

On July 10, the Senate unanimously passed the Affordable Prescriptions for Patients Act of 2023 (S.150), which seeks to increase competition and lower drug prices by imposing limits on patent litigation related to biological...more

9/5/2024 / Biosimilars , BPCIA , Drug Pricing , Food and Drug Administration (FDA) , Patent Infringement , Patents , Pharmaceutical Industry , Pharmaceutical Patents , Proposed Legislation

FDA Issues Final Rule on Laboratory-Developed Tests

On April 29, 2023, the FDA announced a final rule on regulation of laboratory developed tests (LDTs). The rule explicitly categorizes in vitro diagnostic products (IVDs) intended for clinical use as medical devices, which are...more

5/2/2024 / Enforcement , Final Rules , Food and Drug Administration (FDA) , Laboratory Developed Tests , Medical Devices

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