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 ...

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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 ...

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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 ...

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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 ...

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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.  ...

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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 ...

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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 ...

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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 ...

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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, ...

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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 ...

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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. ...

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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 ...

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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.  ...

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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 ...

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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 ...

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