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 ...

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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. ...

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Is your health data safe as My Health Record hacking revealed

20 May 2020 - The government's My Health Record platform was the target of an attempted hack last year, Australia's ...

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Regulatory and health technology assessment advice on post‐licensing and post‐launch evidence generation is a foundation for lifecycle data collection for medicines

11 March 2020 - The understanding of the benefit risk profile, and relative effectiveness of a new medicinal product, are initially ...

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HHS finalises historic rules to provide patients more control of their health data

9 March 2020 - Final rules require access to health information, spur innovation and aim to end information blocking ...

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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 ...

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NICE plans to widen the net for data it uses in guidance

5 February 2020 - UK cost-effectiveness body NICE has said it intends to use a broader range of data and ...

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Broader types of data to be used in development of NICE guidance

4 February 2020 - An expanded evidence base could allow NICE to address evidence gaps and enhance reviews of the impact ...

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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 ...

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Registry-data – of sufficient quality – are suitable for the extended benefit assessment of drugs

24 January 2020 - Rapid report shows how routine practice data should be collected and processed. ...

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Will the FDA give the go-ahead to a prescription video game? The wait goes on, as new data come in.

21 January 2020 - In mid 2018, the startup Akili Interactive Labs asked the Food and Drug Administration to let ...

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Ten recommendations to unlock the potential of big data for public health in the EU

20 January 2020 - The joint Big Data Task Force of EMA and the Heads of Medicines Agencies proposes ten ...

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Sharing health care data with digital giants

16 January 2020 - Overcoming obstacles and reaping benefits while protecting patients. ...

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FDA approves drugs faster than ever but relies on weaker evidence, researchers find

14 January 2020 - The FDA has gotten faster at approving new prescription drugs over the past four decades, but ...

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FDA real world evidence to be made available on Google Cloud

8 January 2020 - The company is making the agency's open-source MyStudies platform available, enabling for easier access to data for ...

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