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20 February 2020
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

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20 February 2020
With full application of the EU Medical Device Regulation (EU MDR) just around the corner on 26 May 2020, it’s fair to say many device manufacturers and regulatory professionals are on edge. And although we are coming to the end of the three-year ...
19 February 2020
Following a successful pilot that wrapped up in August, Health Canada says it will immediately begin accepting certain clinical trial submissions in electronic common technical document (eCTD) format.
19 February 2020
The US Food and Drug Administration (FDA) on Wednesday issued a new draft guidance consolidating its recommendations on nonclinical safety evaluations for immunotoxicity and withdrew an earlier 2002 guidance on the topic.
19 February 2020
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
18 February 2020
The US Food and Drug Administration (FDA) on Tuesday released a report detailing the scientific research carried out and funded by the agency in FY2019 to support the development of generic drugs under the Generic Drug User Fee Amendments (GDUFA...
18 February 2020
More than two years after opening public consultations on the guidelines, the European Medicines Agency (EMA) on Tuesday adopted two International Council for Harmonisation (ICH) guidelines, the ICH E9(R1) addendum on estimands and sensitivity ana...