The Biosimilars Forum joins calls for FDA action on biosimilar communications

3 December 2018 - The Biosimilars Forum is lending its support to Pfizer’s August 2018 citizen petition to the FDA ...

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What should patients be told about non-inferiority studies?

21 August 2017 - A non-inferiority trial is a study in which a new treatment is compared with an existing, already ...

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EMA launches second communication perception survey

11 May 2017 - The EMA has launched its bi-annual communication perception surveyExternal link icon. ...

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Statement from FDA Commissioner announcing new draft guidances on medical product communications

18 January 2017 - We recognise that there is a high level of interest regarding FDA’s views on communications about ...

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EMA goes electronic for PDCO opinions and subsequent EMA decisions

6 July 2016 - As of 1 August 2016, PDCO opinions and subsequent EMA decisions will be transmitted to applicants electronically ...

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