Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 14 Jan 2020
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 ...
Posted by Michael Wonder on 09 Jan 2020
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 ...
Posted by Michael Wonder on 30 Nov 2019
Big data
27 November 2019 - Massive amounts of data are generated on a daily basis that could potentially be harnessed to ...
Posted by Michael Wonder on 21 Nov 2019
The challenges of sharing data in an era of politicised science
21 November 2019 - The goal of making science more transparent—sharing data, posting results on trial registries, use of preprint servers, ...
Posted by Michael Wonder on 14 Nov 2019
10 year update on study results submitted to ClinicalTrials.gov
14 November 2019 - A decade after ClinicalTrials.gov launched a database for reporting results of clinical trials, the database includes results ...
Posted by Michael Wonder on 12 Nov 2019
Google’s ‘Project Nightingale’ gathers personal health data on millions of Americans
11 November 2019 - Search giant is amassing health records from Ascension facilities in 21 states; patients not yet informed. ...
Posted by Michael Wonder on 29 Oct 2019
In generic drug plants in China and India, data falsification is still a problem
29 October 2019 - As the generic drug industry faces allegations of data manipulation, headlines about carcinogen-tainted blood pressure medicine, ...
Posted by Michael Wonder on 12 Oct 2019
Canada's decision to make public more clinical trial data puts pressure on FDA
11 October 2019 - Last March, Canada's department of health changed the way it handles the huge amount of data ...
Posted by Michael Wonder on 01 Oct 2019
FDA informs patients, providers and manufacturers about potential cybersecurity vulnerabilities for connected medical devices and health care networks that use certain communication software
1 October 2019 - Today, the U.S. FDA is informing patients, health care professionals, IT staff in health care facilities and ...
Posted by Michael Wonder on 25 Sep 2019
Paper by European regulators foresees "continuing reduction in clinical data requirements" for biosimilars
24 September 2019 - This month, Elena Wolff-Holz, chair of the EMA’s Biosimilar Medicinal Products Working Party, together with co-authors from ...
Posted by Michael Wonder on 18 Sep 2019
Susan G. Komen Big Data for Breast Cancer Initiative: how patient advocacy organisations can facilitate using big data to improve patient outcomes
12 September 2019 - Integrating different types of data, including electronic health records, imaging data, administrative and claims databases, large data ...
Posted by Michael Wonder on 15 Sep 2019
The startup that manipulated data to get a miracle drug to market
14 September 2019 - AveXis had a revolutionary gene therapy for babies with a deadly disease, and sold to Novartis for ...
Posted by Michael Wonder on 09 Sep 2019
Reeling from scandal, Novartis vows to voluntarily release info on manipulated data in the future
9 September 2019 - Seeking to appease angry regulators, Novartis committed to notifying the FDA within five business days of ...