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19 July 2018Americas

FDA’s Gottlieb launches biosimilars action plan

The US Food and Drug Administration (FDA) 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.

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11 October 2018   The US Food and Drug Administration has released guidance intended to advance the development of generic versions of complex medical drugs.
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More on this story

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11 October 2018   The US Food and Drug Administration has released guidance intended to advance the development of generic versions of complex medical drugs.
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26 October 2018   The US Food and Drug Administration’s generic drug approval rate has increased at a “rapid rate” since January 2017, despite the number of branded drug patent expirations declining during this period.
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