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3 January 2018Americas

FDA reveals further steps to encourage generic competition

The US Food and Drug Administration (FDA) revealed additional steps aimed at encouraging generic competition today.

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More on this story

Americas
FDA identifies companies ‘potentially blocking access’ to drug samples
21 May 2018   The US Food and Drug Administration has published a list of companies that it suspects might be preventing generic drug producers accessing samples of branded products.
Americas
FDA issues latest guidance to stop ‘gaming’ of system
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.
Big Pharma
FDA to focus on data in new ‘top strategic priority’
7 December 2018   The US Food and Drug Administration has announced a new strategy for the use of “real-world evidence” and “real-world data” to improve its regulation of new drugs.

More on this story

Americas
FDA identifies companies ‘potentially blocking access’ to drug samples
21 May 2018   The US Food and Drug Administration has published a list of companies that it suspects might be preventing generic drug producers accessing samples of branded products.
Americas
FDA issues latest guidance to stop ‘gaming’ of system
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.
Big Pharma
FDA to focus on data in new ‘top strategic priority’
7 December 2018   The US Food and Drug Administration has announced a new strategy for the use of “real-world evidence” and “real-world data” to improve its regulation of new drugs.

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