FDA to increase drug competition and speed up ANDA reviews
The US Food and Drug Administration (FDA) has revealed plans to increase competition in the US market for prescription drugs, as well as to facilitate the entry of generic drugs into the market.
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3 October 2018 Scott Gottlieb, commissioner of the Food and Drug Administration,, yesterday announced another set of guidelines aimed at facilitating the entry of generic drugs to the market and preventing “gaming” of the approval system.
19 July 2018 The US Food and Drug Administration is not going to play regulatory ‘whack-a-mole’ with companies trying to delay or derail the entry of biosimilar competitors, according to Scott Gottlieb, commissioner of the FDA.