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Podcast: レアジョブ英会話 Daily News Article Podcast
Episode: FDA will drop two-study requirement for new drug approvals, aiming to speed access
Description: The Food and Drug Administration (FDA) plans to drop its longtime standard of requiring two rigorous studies to win approval for new drugs, the latest change from Trump administration officials vowing to speed up the availability of certain medical products.
Going forward, the FDA's “default position” will be to require one study for new drugs and other novel health products, FDA Commissioner Dr. Marty Makary and a top deputy, Dr. Vinay Prasad, wrote in a piece published in the New England Journal of Medicine.
The announcement is the latest example of Makary and his team changing long-standing FDA standards and proc...