Global regulatory workshop on COVID-19 therapeutics #2: agreement on acceptable outcomes for clinical trials

31 July 2020 - International regulators have published a report today on the acceptability of various primary outcomes in the ...

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The use of validated and non-validated surrogate endpoints in two EMA expedited approval pathways: A cross-sectional study of products authorised 2011–2018

10 September 2019 - In situations of unmet medical need or in the interests of public health, expedited approval pathways, ...

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Minimal residual disease as a surrogate outcome for product development for multiple myeloma: comparing FDA and EMA guidances

8 April 2019 - This article discusses the need to update regulatory science to include the use of minimal residual disease ...

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