Will the Food and Drug Administration’s New Standard of Requiring Only One Trial for a New Drug Application/Biologic License Application Have Repercussions for Medical Communicators?
DOI:
https://doi.org/10.55752/amwa.2026.569Abstract
On February 19, Prasad and Makary published a “Sounding Board” opinion piece in the New England Journal of Medicine (NEJM).1 They announced that the Food and Drug Administration (FDA) will move away from its long standing practice of requiring 2 well-controlled clinical trials for marketing approval. From now on, a single pivotal trial—supported by “additional evidence” (for example, biomarker data, mechanistic evidence, real-world data, or postmarketing surveillance)—will become the new default for many drug approvals.
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