Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. WASHINGTON — The Food and Drug ...
Last week, FDA Commissioner Marty Makary, MD, MPH, announced plans to officially lower the standard for how many clinical trials are needed to approve a new drug -- from the long-standing expectation ...
The US Food and Drug Administration (FDA) will allow sponsors to file for drug approval with just one pivotal trial instead of two. A paper, published in the New England Journal of Medicine (NEJM), by ...
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