Blog
RSS FeedPosted by Michael Wonder on 26 Apr 2018
Mission possible: moving the needle forward to advance health equity
26 April 2018 - Every April our country observes National Minority Health Month to spotlight what we’re doing to eliminate health ...
Posted by Michael Wonder on 03 Apr 2018
FDA charts path forward for biosimilars — but drug makers aren’t all on board
30 March 2018 - In his recent public appearances, FDA Commissioner Scott Gottlieb has sounded a repeating note: drug prices ...
Posted by Michael Wonder on 30 Mar 2018
Statement from FDA Commissioner on FDA’s efforts to enhance the patient perspective and experience in drug development and review
30 March 2018 - Benefit-risk assessment is at the heart of what we do to ensure that Americans have access ...
Posted by Michael Wonder on 22 Mar 2018
FDA wants to help unproductive drug makers
22 March 2018 - America’s pharmaceutical giants may also need to rethink their business model. ...
Posted by Michael Wonder on 20 Mar 2018
FDA, industry ponder changes to clinical trials for rare disease treatments
19 March 2018 - FDA statisticians pondered changing how the agency uses statistics to approve drugs for rare disease at ...
Posted 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 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. ...