26 October 2021 - An international expert committee, informed by the methodological framework for guideline development of the Enhancing the Quality ...
21 October 2021 - Today, the U.S. FDA issued a draft guidance for industry titled Data Standards for Drug and Biological ...
29 September 2021 - The intent of this guidance is to clarify for drug sponsors and other stakeholders how considerations about ...
10 August 2021 - The FDA announced its finalised guidance on the use of metastases-free survival as an outcome for ...
3 August 2021 - To help patients with cancer learn more about how treatment may affect their quality of life, the ...
9 June 2021 - This guidance provides recommendations to sponsors for collection of a core set of patient reported clinical outcomes ...
26 May 2021 - Today, the U.S. FDA issued two guidances regarding the surveillance of certain medical devices. ...
20 May 2021 - This guidance represents FDA’s current thinking on adjusting for covariates in the statistical analysis of randomised clinical ...
9 November 2020 - To further promote and protect public health, it is important that people who are in clinical trials ...
6 October 2020 - Today, the U.S. FDA issued guidance with recommendations for vaccine sponsors regarding the scientific data and ...
2 October 2020 - The BIO trade group, whose members include most of the vaccine makers, asked the health secretary to ...
31 August 2020 - Device manufacturers have new draft guidance from the US FDA for the selection of patient-reported outcome ...
27 August 2020 - Today, the U.S. FDA issued a draft guidance document, “Evaluating Cancer Drugs in Patients with Central Nervous ...
18 August 2020 - More than 750,000 deaths have occurred worldwide as a result of the novel coronavirus as of ...
17 August 2020 - The purpose of this guidance is to assist sponsors in the clinical development of drugs and biological ...