U.S. regulators defend requiring more data on monkeypox drug

4 August 2022 - As U.S. monkeypox cases rise, U.S. health agencies in a medical journal article published on Wednesday ...

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Big data use for public health: publication of Big Data Steering Group workplan 2022-25

28 July 2022 - The Big Data Steering Group set up by EMA and the Heads of Medicines Agencies has ...

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EMA launches pilot project on analysis of raw data from clinical trials

12 July 2022 - EMA has launched a pilot project to assess whether the analysis of ‘raw data’ from clinical ...

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Choices that fail health and wellbeing

5 May 2022 - NICE's expert group RAPID C-19, set up to ‘to ensure safe and timely patient access to treatments ...

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Supply related data in manufacturer dossiers: things are not going smoothly yet

19 April 2022 - The criteria for supply related data established by IQWiG in 2020 were positively received in science.  ...

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COVID-19 vaccines: individual patient data should be submitted to the European Medicines Agency

24 February 2022 - An interesting letter to the Editor of the BMJ from the Head of Drug Assessment at ...

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Assessment of public opinion on transparency at the US Food and Drug Administration

18 February 2022 - Historically, the US FDA has considered much of the oversight of clinical trials, interactions with companies, and ...

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WHO’s new International Classification of Diseases (ICD-11) comes into effect

11 February 2022 - The World Health Organization Eleventh Revision of the International Classification of Diseases (ICD-11) has now come ...

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The FDA and its new commissioner must follow the science

13 February 2022 - The FDA has the awesome responsibility to protect public health by ensuring the safety and effectiveness of ...

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Pfizer pushes to intervene in lawsuit seeking COVID vaccine information from FDA

27 January 2022 - Pfizer wants to intervene in a Texas federal lawsuit seeking information from the U.S. FDA used ...

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COVID-19 vaccines and treatments: we must have raw data, now

19 January 2022 - Data should be fully and immediately available for public scrutiny ...

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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 ...

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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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