Blog
RSS FeedPosted 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 20 May 2020
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 ...
Posted by Michael Wonder on 16 Mar 2020
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 ...
Posted by Michael Wonder on 09 Mar 2020
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 ...
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 05 Feb 2020
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 ...
Posted by Michael Wonder on 04 Feb 2020
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 ...
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 ...
Posted by Michael Wonder on 25 Jan 2020
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. ...
Posted by Michael Wonder on 21 Jan 2020
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 ...
Posted by Michael Wonder on 20 Jan 2020
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 ...