Blog
RSS FeedPosted by Michael Wonder on 19 Sep 2016
FDA launches competition to spur innovative technologies to help reduce opioid overdose deaths
19 September 2016 - Contest seeks to stimulate development of a mobile app to connect those experiencing an overdose with the ...
Posted by Michael Wonder on 08 Sep 2016
Fighting antimicrobial resistance globally
7 September 2016 - EMA, FDA and PMDA discuss regulatory approaches for the evaluation of new anti-bacterial agents. ...
Posted by Michael Wonder on 19 Aug 2016
“Adaptive pathways” to drug authorisation: adapting to industry?
16 August 2016 - The evidence for benefits of adaptive pathways to patients and public health is lacking or contradictory, ...
Posted by Michael Wonder on 17 Aug 2016
German body calls for pause in European plan for fast track drug approval
16 August 2016 - Plans by the European Medicines Agency to expand its fast track approach to approving new drugs have ...
Posted by Michael Wonder on 17 Aug 2016
The FDA, Juno Therapeutics, and the ethical imperative of transparency
15 August 2016 - Despite deaths, investigational new drugs are still protected trade secrets of the manufacturer. ...
Posted by Michael Wonder on 16 Aug 2016
Addressing challenges of innovative cancer immunotherapy medicines
16 August 2016 - EMA workshop to discuss treatments based on genetically modified T-cells. ...
Posted by Michael Wonder on 16 Aug 2016
German agency criticizes European program for speeding some drug approvals
15 August 2016 - in pointed remarks, Germany’s cost-effectiveness watchdog has criticized an effort by European regulators to accelerate approval ...
Posted by Michael Wonder on 11 Aug 2016
The future of cardiovascular medicine from the regulatory perspective
10 August 2016 - For many years, the American public and the entire world have benefited from the U.S. FDAs’ regulatory ...
Posted by Michael Wonder on 09 Aug 2016
Adaptive pathways: EMA still leaves open questions unanswered
9 August 2016 - Current EMA report on the pilot project again documents perplexity regarding the use of “real world data”. ...
Posted by Michael Wonder on 04 Aug 2016
Adaptive pathways: key learnings and next steps
3 August 2016 - EMA publishes report on pilot project and will organise workshop in December to further explore concept ...
Posted by Michael Wonder on 03 Aug 2016
New layout for EMA scientific guidelines
2 August 2016 - Improved presentation to help website users. ...
Posted by Michael Wonder on 01 Aug 2016
Development of medicines to treat tuberculosis
1 August 2016 - Comments on draft guidance invited until 31 January 2017. ...
Posted by Michael Wonder on 31 Jul 2016
Modelling and simulation in the development and regulatory review of medicines
29 July 2016 - Comments on new guidance invited until 31 January 2017. ...
Posted by Michael Wonder on 21 Jul 2016
Proposals to revise guidance on first-in-human clinical trials
21 July 2016 - Comments invited on a concept paper on changes intended to support best practices. ...
Posted by Michael Wonder on 05 Jul 2016
Top officials aim to reshape the FDA to prepare for 'avalanche' of cancer products
30 June 2016 - For 20 years, Richard Pazdur has run the office of the FDA charged with evaluating new cancer ...