Blog
RSS FeedPosted by Michael Wonder on 27 Jul 2017
EU report: more evidence on link between antibiotic use and antibiotic resistance
27 July 2017 - The European Food Safety Authority, the European Medicines Agency and the European Centre for Disease Prevention ...
Posted by Michael Wonder on 26 Jul 2017
Trump's FDA Commissioner on drug prices, regulations, science
25 July 2017 - U.S. FDA Commissioner Scott Gottlieb spoke with Bloomberg News about drug pricing, new medicine and regulations. ...
Posted by Michael Wonder on 25 Jul 2017
Practical improvements for medical device evaluation
25 July 2017 - Passage of the Medical Device Amendments Act in 1976 confirmed the US FDA’s primary responsibility for evaluating ...
Posted by Michael Wonder on 20 Jul 2017
Keeping the U.S. prescription drug supply chain among the safest in the world
20 July 2017 - The U.S. prescription drug supply is among the safest in the world, but it can be challenging ...
Posted by Michael Wonder on 20 Jul 2017
FDA may publicly shame drug makers for thwarting generic rivals
19 July 2017 - Attention brand-name drug makers: the FDA may soon publicly shame you for thwarting generic rivals. ...
Posted by Michael Wonder on 19 Jul 2017
Involving young people in EMA activities
19 July 2017 - New principles give a voice to patients, consumers and carers under age 18. ...
Posted by Michael Wonder on 17 Jul 2017
Building a strong FDA workforce to bring scientific advances to patients
17 July 2017 - The key to FDA’s public health mission, and its ability to bring innovative new therapies to patients, ...
Posted by Michael Wonder on 13 Jul 2017
House poised to pass bill critical for drug industry; the Senate may be a slog
12 July 2017 - The House of Representatives is fast-tracking a vote on a key priority for the pharmaceutical industry, ...
Posted by Michael Wonder on 13 Jul 2017
Multidimensional evidence generation and FDA regulatory decision making defining and using “real-world” data
13 July 2017 - Evidence linking interventions with health outcomes is the basis for good health care decision making. ...
Posted by Michael Wonder on 11 Jul 2017
Two recent scientific advances underscore an encouraging future for precision medicine at FDA
11 July 2017 - FDA helps bring precision medicine – in the form of targeted therapies — to people living ...
Posted by Michael Wonder on 11 Jul 2017
First gene therapy — ‘a true living drug’ — on the cusp of FDA approval
11 July 2017 - When doctors saw the report on Bill Ludwig’s bone-marrow biopsy, they thought it was a mistake ...
Posted by Michael Wonder on 11 Jul 2017
EMA seeks views of public during its safety review of valproate
11 July 2017 - Registration opens for first public hearing ...
Posted by Michael Wonder on 11 Jul 2017
TGA to be one-stop shop for complaints
10 July 2017 - The TGA will be given full responsibility over advertising complaints for medicines and medical devices in ...
Posted by Michael Wonder on 10 Jul 2017
TGA to improve the handling of advertising complaints
10 July 2017 - Australia’s therapeutic goods regulator is implementing new arrangements to simplify and improve the handling of complaints about ...
Posted by Michael Wonder on 09 Jul 2017
EMA restricts use of multiple sclerosis medicine Zinbryta
7 July 2017 - Restrictions are provisional measures while review of liver safety is on-going. ...