Blog
RSS FeedPosted by Michael Wonder on 27 May 2017
Drug approvals bounce back as R&D labs churn out new winners
25 May 2017 - The number of new drugs approved for sale in United States and Europe has bounced back ...
Posted by Michael Wonder on 23 May 2017
New FDA pathway to accelerate development of cell therapies
22 May 2017 - Four products have already qualified for the regenerative medicine advanced therapy designation that provides extra interactions with ...
Posted by Michael Wonder on 22 May 2017
Drugs approved with limited data aren’t always well-tested later
19 May 2017 - New medicines that win U.S. marketing approval without conclusive evidence of their effectiveness aren't always proven ...
Posted by Michael Wonder on 22 May 2017
Green light given for new EudraVigilance system for collection and monitoring of suspected adverse reactions
22 May 2917 - Management Board endorsement starts countdown for stakeholders to get ready for launch of improved system in ...
Posted by Michael Wonder on 20 May 2017
Janssen files suit in U.S. to block sale of Samsung Bioepis' Remicade copy
18 May 2017 - A unit of healthcare conglomerate Johnson & Johnson filed a lawsuit to block a copy of ...
Posted by Michael Wonder on 20 May 2017
Britain without the EMA
17 May 2017 - Brexit has serious consequences for drug regulation and pharmacovigilance, but as Nigel Hawkes reports, little thought ...
Posted by Michael Wonder on 17 May 2017
Brexit’s potential health benefits
16 May 2017 - An opportunity exists to modify outdated regulatory system specifically for the UK. ...
Posted by Michael Wonder on 16 May 2017
Dr. Gottlieb’s first remarks to FDA staff
15 May 2017 - It’s an honor to be here today, and to be taking on this responsibility with all ...
Posted by Michael Wonder on 16 May 2017
Reducing preventable harm from medications: too big for FDA to do alone
16 May 2017 - Sometimes a drug can be used exactly as FDA approved it, taken just the way a doctor ...
Posted by Michael Wonder on 15 May 2017
EMA publishes draft agenda for May CHMP meeting
15 May 2017 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 15 May 2017
Publication and reporting of the results of post-market studies for drugs required by the US FDA, 009 to 2013
15 May 2017 - Advancing scientific knowledge depends on the timely dissemination of research results, including those from medical product research ...
Posted by Michael Wonder on 11 May 2017
Billions saved because FDA didn't rush approval of Alzheimer's drug
10 May 2017 - The U.S. FDA's decision not to rush approval for Eli Lilly's experimental Alzheimer's treatment solanezumab - ...
Posted by Michael Wonder on 11 May 2017
EMA launches second communication perception survey
11 May 2017 - The EMA has launched its bi-annual communication perception surveyExternal link icon. ...
Posted by Michael Wonder on 10 May 2017
Progress on science, medicines and health
10 May 2017 - The EMA\'s 2016 annual report published today focuses on the Agency’s key achievements in the areas ...
Posted by Michael Wonder on 10 May 2017
Senate confirms Trump's pick for FDA
9 May 2017 - The Senate on Tuesday confirmed Scott Gottlieb, President Trump's nominee to lead the FDA. ...