18 February 2021 - Current examples show that the 15% threshold newly set by IQWiG for the recognition of responder analyses ...
11 December 2020 - The public posting of a surrogate endpoint table for both reasonably likely and validated surrogate outcomes was ...
11 September 2020 - In the drive towards faster patient access to treatments, health technology assessment agencies are increasingly faced with ...
31 July 2020 - International regulators have published a report today on the acceptability of various primary outcomes in the ...
29 July 2020 - This guidance is intended to assist sponsors in designing trials to support marketing approval of medicines and ...
13 April 2020 - In July 2018, the FDA first published a table listing all surrogate measures that it has used, ...
27 February 2020 - Randomised clinical trials have a long history of success in many medical arenas. ...
13 November 2019 - The US FDA needs to reconsider its use of surrogate outcomes in some guidance documents on ...
10 September 2019 - In situations of unmet medical need or in the interests of public health, expedited approval pathways, ...
27 July 2019 - At the 24th Congress of the European Hematology Association in June, 2019, the results of the BELLINI ...
24 July 2019 - Two-and-a-half years after its release, the US FDA is asking for input from the public on ...
8 April 2019 - This article discusses the need to update regulatory science to include the use of minimal residual disease ...
17 January 2019 - The FDA has revised its draft guidance for developing rare disease treatments to include the use ...
19 December 2018 - Today, the U.S. FDA issued guidance, Clinical Trial Endpoints for the Approval of Cancer Drugs and ...
12 December 2018 - On 13 February 2018, the US FDA granted marketing authorisation to apalutamide for treatment of non-metastatic castration-resistant ...