Blog
RSS FeedPosted by Michael Wonder on 11 Mar 2018
Key design considerations for adaptive clinical trials: a primer for clinicians
8 March 2018 - This article reviews important considerations for researchers who are designing adaptive clinical trials. ...
Posted by Michael Wonder on 08 Mar 2018
Balancing safety and innovation for cell-based regenerative medicine
8 March 2018 - Regenerative medicine is a field that involves replacing, engineering, or regenerating human cells, tissues, or organs to ...
Posted by Michael Wonder on 05 Mar 2018
Guided by the research design: choosing the right statistical test
5 March 2018 - Choosing the right statistical test or model can be baffling for researchers, and if it is not ...
Posted by Michael Wonder on 28 Feb 2018
Europe follows FDA with plans to help early Alzheimer's drugs
28 February 2018 - European regulators are following in the footsteps of the U.S. Food and Drug Administration with plans ...
Posted by Michael Wonder on 28 Feb 2018
Drug makers lobby for antibiotic incentives in pandemic preparedness bill
27 February 2018 - A big legislative package due for renewal later this year could include hundreds of millions of ...
Posted by Michael Wonder on 26 Feb 2018
Statement from FDA Commissioner on FDA’s ongoing efforts to help improve effectiveness of influenza vaccines
26 February 2018 - The current influenza season has been especially difficult, causing widespread illness that has affected all fifty ...
Posted by Michael Wonder on 26 Feb 2018
Contribution of NIH funding to new drug approvals 2010–2016
12 February 2018 - This report shows that NIH funding contributed to published research associated with every one of the 210 ...
Posted by Michael Wonder on 22 Feb 2018
Developing anti-cancer drugs in orphan molecular entities — a paradigm under construction
22 February 2018 - Genomic characterisation of cancers has shown that some oncogenic alterations occur at very low frequency and are ...
Posted by Michael Wonder on 19 Feb 2018
RMAT vs. breakthrough vs. fast track: companies seek clarity on FDA draft guidance
19 February 2018 - Industry groups BIO, the Alliance for Regenerative Medicine and the International Society for Cellular Therapy, as well ...
Posted by Michael Wonder on 16 Feb 2018
FDA opens new path for Alzheimer's treatments
16 February 2018 - Draft guidance comes after Merck failure, years of others. ...
Posted by Michael Wonder on 15 Feb 2018
Statement from FDA Commissioner on advancing the development of novel treatments for neurological conditions; part of broader effort on modernizing FDA’s new drug review programs
15 February 2018 - New medical breakthroughs are altering how diseases are treated in ways that seemed unimaginable just a ...
Posted by Michael Wonder on 14 Feb 2018
The stepped-wedge clinical trial
13 February 2018 - Evaluation by rolling deployment. ...
Posted by Michael Wonder on 03 Feb 2018
Strengthened guidance on follow-up and risk management for ATMP developers
2 February 2018 - Guideline to streamline procedures and better address the specific requirements of ATMP developers published for consultation ...
Posted by Michael Wonder on 31 Jan 2018
How to better apply the paediatric legislation to boost development of medicines for children
31 January 2018 - EMA and European Commission invite stakeholders to register for joint workshop and support development of an ...
Posted by Michael Wonder on 30 Jan 2018
The impact of parallel regulatory-HTA scientific advice on clinical development. Assessing the uptake of regulatory and HTA recommendations.
30 January 2018 - The “Parallel regulatory-HTA scientific advice” procedure allows manufacturers to receive simultaneous feedback from both EU regulators and ...