16 August 2023 - For only the fifth time, the FDA recently threatened to fine a company or clinical trial ...
24 March 2023 - The US FDA plans to hold at least one public meeting and release several guidances on digital ...
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. ...
8 September 2022 - To facilitate FDA’s internal tracking of submissions to the Agency that include real world data and real ...
20 July 2022 - In draft guidance issued on Wednesday, the US FDA explains its approach to therapeutic equivalence evaluations and ...
16 March 2022 - The U.S. FDA has issued two draft guidances addressing the development of human gene therapy products that ...
14 February 2022 - Ensuring high quality, affordable generic drugs are available to the American public. ...
27 January 2022 - Clinical trials requiring registration on ClinicalTrials.gov generally must have results submitted no later than one year after ...
19 January 2022 - Data should be fully and immediately available for public scrutiny ...
13 January 2022 - The FDA’s Center for Drug Evaluation and Research has issued its report, Advancing Health Through Innovation: New ...
29 November 2021 - Today, the U.S. FDA issued a draft guidance for industry titled "Real-World Data: Assessing Registries to Support ...
10 August 2021 - The FDA announced its finalised guidance on the use of metastases-free survival as an outcome for ...
9 June 2021 - This guidance provides recommendations to sponsors for collection of a core set of patient reported clinical outcomes ...