Blog
RSS FeedPosted by Michael Wonder on 05 Jul 2017
Patient reported outcomes — are they living up to their potential?
5 July 2017 - There is a growing chorus of support for measuring patient-reported outcomes in clinical care. ...
Posted by Michael Wonder on 03 Jul 2017
EMA and FDA encourage use of innovative approaches in the development of medicines for Gaucher disease
3 July 2017 - Approach aims to facilitate development of medicines for rare paediatric diseases in general. ...
Posted by Michael Wonder on 02 Jul 2017
Fears over a medical gold rush in cancer drug race
3 July 2017 - With almost 800 trials under way observers warn scientific rigour is being compromised. ...
Posted by Michael Wonder on 19 Jun 2017
Emerging use of early health technology assessment in medical product development: a scoping review of the literature
20 June 2017 - Early health technology assessment is increasingly being used to support health economic evidence development during early stages ...
Posted by Michael Wonder on 17 Jun 2017
FDA science: working at the speed of emerging technologies
16 June 2017 - Let’s face it, we’ve all gotten used to nearly instant access to almost anything. ...
Posted by Michael Wonder on 15 Jun 2017
Fostering medical innovation: a plan for digital health devices
15 June 2017 - It is incumbent upon FDA to ensure that we have the right policies in place to promote ...
Posted by Michael Wonder on 12 Jun 2017
Regulators in EU, Japan and US take steps to facilitate development of new antibiotics
12 June 2017 - EMA, PMDA and FDA align data requirements and agree on areas of convergence. ...
Posted by Michael Wonder on 06 Jun 2017
Workshop: addressing unmet needs of children with pulmonary arterial hypertension
6 June 2017 - The EMA, the United States FDA and Health Canada are co-organising a workshop to discuss the ...
Posted by Michael Wonder on 29 May 2017
Designing clinical trials that accept new arms: an example in metastatic breast cancer
22 May 2017 - The majority of randomised oncology trials are two-arm studies that test the efficacy of new therapies against ...
Posted by Michael Wonder on 17 May 2017
How patients are changing clinical trials
17 May 2017 - In September, the FDA approved a controversial drug to treat Duchenne muscular dystrophy, a rare but deadly ...
Posted by Michael Wonder on 23 Mar 2017
An FDA program incentivising rare disease drugs will be investigated for abuses
23 March 2017 - In late 1982, Congress overwhelmingly passed the Orphan Drug Act, which was then signed into law ...
Posted by Michael Wonder on 14 Mar 2017
Logistic regression diagnostics: understanding how well a model predicts outcomes
14 March 2017 - In the 8 March 2016, issue of JAMA, Zemek et al used logistic regression to develop ...
Posted by Michael Wonder on 13 Mar 2017
Review of the drug trials snapshots program of the US FDA: women in cardiovascular drug trials
13 March 2017 - Over the last 20 years, there have been concerns that too few women and minorities are enrolled ...
Posted by Michael Wonder on 04 Mar 2017
GAO: drug makers want more clarity on antibiotic incentives
3 March 2017 - Despite some improvements, drug makers say the US FDA has not fully clarified its expectations for ...
Posted by Michael Wonder on 03 Mar 2017
Trump vows to 'slash restraints' on drug development for FDA
1 March 2017 - President Donald Trump used his first address to a joint session of Congress on Tuesday to, ...