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RSS FeedPosted by Michael Wonder on 10 Aug 2020
Communication@EMA
10 August 2020 - The European Medicines Agency has launched its third communication perception survey. ...
Posted by Michael Wonder on 04 Dec 2018
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 ...
Posted by Michael Wonder on 22 Aug 2017
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 ...
Posted by Michael Wonder on 11 May 2017
EMA launches second communication perception survey
11 May 2017 - The EMA has launched its bi-annual communication perception surveyExternal link icon. ...
Posted by Michael Wonder on 18 Jan 2017
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 ...
Posted by Michael Wonder on 06 Jul 2016
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 ...