30 August 2023 - Today, the US FDA issued a final guidance for industry titled Considerations for the Use of Real-World ...
26 May 2023 - This final guidance describes FDA’s current recommendations regarding adjusting for covariates in the statistical analysis of randomised ...
17 May 2023 - EMA has published recommendations for industry on good practices to ensure continuity in the supply of ...
24 March 2023 - The accelerated approval pathway is commonly used for approval of oncology drugs due to the serious ...
24 March 2023 - The US FDA plans to hold at least one public meeting and release several guidances on digital ...
7 February 2023 - Commenters on the US FDA draft guidance outlining principles for in vivo or in vitro bioequivalence ...
16 December 2022 - This guidance will help sponsors interpret amendments to the Food and Drug Regulations (regulations) requiring them ...
19 December 2022 - The European Commission, the Heads of Medicines Agencies and the EMA have published recommendations that aim to ...
4 November 2022 - The US FDA laid out its recommendations for sponsors to study multiple versions of a cellular or ...
20 October 2022 - The US FDA on Thursday finalised guidance to sponsors on managing multiple outcomes in clinical trials ...
17 October 2022 - This guidance provides recommendations to sponsors regarding considerations for tissue agnostic drug development in oncology. ...
29 September 2022 - EMA is launching a pilot to support the translation of basic research developments into medicines that could ...
8 September 2022 - To facilitate FDA’s internal tracking of submissions to the Agency that include real world data and real ...
19 August 2022 - Rapid innovation and proliferation of software as a medical device have accelerated the clinical use of digital ...
20 July 2022 - In draft guidance issued on Wednesday, the US FDA explains its approach to therapeutic equivalence evaluations and ...