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RSS FeedPosted by Michael Wonder on 21 Jun 2021
TGA not expecting Novavax quality data until September
20 June 2021 - Australian’s medicines regulator says it does not expect key data from the country’s third major COVID-19 ...
Posted by Michael Wonder on 19 May 2021
COVID-19 vaccines: In the rush for regulatory approval, do we need more data?
18 May 2021 - After rollout under emergency authorisation, manufacturers of COVID-19 vaccines now have their sights on regulatory approval. ...
Posted by Michael Wonder on 07 May 2021
International regulators and WHO call for wider public access to clinical data
7 May 2021 - The International Coalition of Medicines Regulatory Authorities and the World Health Organisation are urging pharmaceutical companies to ...
Posted by Michael Wonder on 30 Apr 2021
AstraZeneca struggles with data needed for COVID-19 vaccine’s approval
29 April 2021 - Company is assembling data for FDA review, hoping for another stamp of regulatory backing in global rollout ...
Posted by Michael Wonder on 21 Apr 2021
Switzerland ‘unfortunately’ still awaiting AstraZeneca COVID-19 vaccine data
21 April 2021 - Switzerland’s drug regulator is still awaiting data needed to consider whether to approve AstraZeneca’s COVID-19 vaccine, ...
Posted by Michael Wonder on 10 Dec 2020
Hackers steal Pfizer/BioNTech COVID-19 vaccine data in Europe, companies say
10 December 2020 - U.S. drug maker Pfizer and its German partner BioNTech said on Wednesday that documents related to development ...
Posted by Michael Wonder on 30 Nov 2020
Deploying big data to determine how well vaccines work
29 November 2020 - As the initial rollout starts, it’s time to start planning a registry to monitor health outcomes. ...
Posted by Michael Wonder on 28 Sep 2020
Worst-rank score methods—a non-parametric approach to informatively missing data
28 September 2020 - A previous JAMA Guide to Statistics and Methods article briefly reviewed non-parametric statistics. ...
Posted by Michael Wonder on 14 Sep 2020
Making best use of big data for public health: publication of the Big Data Steering Group workplan for 2020-21
14 September 2020 - The Big Data Steering Group set up by EMA and the Heads of Medicines Agencies has ...
Posted by Michael Wonder on 25 Aug 2020
F.D.A. ‘grossly misrepresented’ blood plasma data, scientists say
24 August 2020 - Many experts — including a scientist who worked on the Mayo Clinic study — were bewildered about ...
Posted by Michael Wonder on 24 Aug 2020
FDA may fine clinical trial sponsors that don’t report data
24 August 2020 - The US FDA has said it will penalise sponsors of clinical trials that do not report ...
Posted by Michael Wonder on 03 Jun 2020
EMA weighs COVID-19 data transparency, not ready to resume full clinical data publication
1 June 2020 - In a response to officials at Germany’s IQWiG and the Cochrane Collaboration, EMA Executive Director Guido ...
Posted by Michael Wonder on 24 May 2020
Federal scientists finally publish remdesivir data
23 May 2020 - A clinical trial led to the authorisation of the only drug shown to work in COVID-19 patients. ...
Posted by Michael Wonder on 22 Feb 2020
FDA launches new resource to provide easily accessible, more accurate historical drug approval data
21 February 2020 - FDA is launching a new resource to assist external and agency researchers collecting historical information about ...
Posted by Michael Wonder on 29 Jan 2020
FDA launches mobile-friendly database with information on life-saving HIV drugs as part of ongoing mission to empower the public through increased access to information and data
29 January 2020 - Interactive tool offers information on ARVs eligible for purchase under the President’s Emergency Plan for AIDS Relief ...