20 June 2021 - Australian’s medicines regulator says it does not expect key data from the country’s third major COVID-19 ...
18 May 2021 - After rollout under emergency authorisation, manufacturers of COVID-19 vaccines now have their sights on regulatory approval. ...
7 May 2021 - The International Coalition of Medicines Regulatory Authorities and the World Health Organisation are urging pharmaceutical companies to ...
29 April 2021 - Company is assembling data for FDA review, hoping for another stamp of regulatory backing in global rollout ...
21 April 2021 - Switzerland’s drug regulator is still awaiting data needed to consider whether to approve AstraZeneca’s COVID-19 vaccine, ...
10 December 2020 - U.S. drug maker Pfizer and its German partner BioNTech said on Wednesday that documents related to development ...
29 November 2020 - As the initial rollout starts, it’s time to start planning a registry to monitor health outcomes. ...
28 September 2020 - A previous JAMA Guide to Statistics and Methods article briefly reviewed non-parametric statistics. ...
14 September 2020 - The Big Data Steering Group set up by EMA and the Heads of Medicines Agencies has ...
24 August 2020 - Many experts — including a scientist who worked on the Mayo Clinic study — were bewildered about ...
24 August 2020 - The US FDA has said it will penalise sponsors of clinical trials that do not report ...
1 June 2020 - In a response to officials at Germany’s IQWiG and the Cochrane Collaboration, EMA Executive Director Guido ...
23 May 2020 - A clinical trial led to the authorisation of the only drug shown to work in COVID-19 patients. ...
21 February 2020 - FDA is launching a new resource to assist external and agency researchers collecting historical information about ...
29 January 2020 - Interactive tool offers information on ARVs eligible for purchase under the President’s Emergency Plan for AIDS Relief ...