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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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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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6 March 2019   Scott Gottlieb, commissioner of the US Food and Drug Administration, resigned from his post yesterday, March 5, with plans to step down in the next month.

More on this story

Americas
11 October 2018   The US Food and Drug Administration has released guidance intended to advance the development of generic versions of complex medical drugs.
Americas
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.
Americas
6 March 2019   Scott Gottlieb, commissioner of the US Food and Drug Administration, resigned from his post yesterday, March 5, with plans to step down in the next month.

More on this story

Americas
11 October 2018   The US Food and Drug Administration has released guidance intended to advance the development of generic versions of complex medical drugs.
Americas
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.
Americas
6 March 2019   Scott Gottlieb, commissioner of the US Food and Drug Administration, resigned from his post yesterday, March 5, with plans to step down in the next month.