Blog
RSS FeedPosted by Michael Wonder on 22 Jan 2022
COVID-19 vaccines and treatments: we must have raw data, now
19 January 2022 - Data should be fully and immediately available for public scrutiny ...
Posted by Michael Wonder on 26 Oct 2021
Generating high quality evidence from registry based studies
26 October 2021 - EMA has published guidance to provide key methods and good regulatory practices to pharmaceutical organisations on ...
Posted by Michael Wonder on 15 Sep 2021
FDA advances data, IT modernisation efforts with new Office of Digital Transformation
15 September 2021 - FDA prioritises effective and efficient use of data by reorganising IT, data and cybersecurity functions to ...
Posted by Michael Wonder on 02 Aug 2021
Working towards harmonised access to clinical trial data across European drug regulatory agencies
31 July 2021 - On 31 May 2021, a group of researchers and NGOs submitted an open letter to the ...
Posted by Michael Wonder on 13 Jul 2021
European efforts to assess Russia’s Sputnik V vaccine stymied by data gaps
13 July 2021 - The developers of Russia’s Sputnik V coronavirus vaccine have repeatedly failed to provide data that regulators ...
Posted 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 29 Apr 2021
Australia has surpassed 2 million vaccines but lacks data on second doses
28 April 2021 - Australians will not be told how many people have received a second dose of the COVID-19 vaccine ...
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 12 Nov 2020
PHARMAC won’t release the data that changed its mind on diabetes
13 November 2020 - Diabetes Foundation Aotearoa will request the Ombudsman investigate the refusal by PHARMAC to release public submissions ...
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. ...