Blog
RSS FeedPosted by Michael Wonder on 08 Oct 2020
Use of real world evidence to support FDA approval of oncology drugs
8 October 2020 - Real world evidence has gained increased attention in recent years as a complement to traditional clinical trials. ...
Posted by Michael Wonder on 08 Oct 2020
Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study
7 October 2020 - The investigators of the study set out to characterise the therapeutic value of new drugs approved ...
Posted by Michael Wonder on 08 Oct 2020
To maintain trust and respectability, digital health companies must commit to the highest standards
7 October 2020 - The digital health gold rush is on. Teledoc’s $18.5 billion acquisition of Livongo reflects the valuation ...
Posted by Michael Wonder on 05 Oct 2020
CDER proposes withdrawal of approval for Makena
5 October 2020 - Today, the U.S. FDA’s Center for Drug Evaluation and Research proposed that Makena (hydroxyprogesterone caproate injection) ...
Posted by Michael Wonder on 05 Oct 2020
Real world evidence from a narrow therapeutic index product (levothyroxine) reflects the therapeutic equivalence of generic drug product
5 October 2020 - The National Institute of Diabetes and Digestive and Kidney Diseases reports that almost 5% of the U.S. ...
Posted by Michael Wonder on 30 Sep 2020
The FDA and the importance of trust
30 September 2020 - As SARS-CoV-2 emerged, the global scientific community first studied the virus at the bench, then took what ...
Posted by Michael Wonder on 30 Sep 2020
Study identifies shortcomings in FDA evaluations for new opioid drug approvals over two decades
29 September 2020 - Systematic assessment of safety-related outcomes has been lacking, researchers find. ...
Posted by Michael Wonder on 29 Sep 2020
Increase transparency at the FDA: we need sunlight to fight the pandemic
29 September 2020 - The FDA has issued a number of contentious decisions during the COVID-19 pandemic related to investigational ...
Posted by Michael Wonder on 25 Sep 2020
FDA takes actions to help lower U.S. prescription drug prices
24 September 2020 - Final rule, guidance fulfil plan for safe importation of certain drugs originally intended for foreign markets. ...
Posted by Michael Wonder on 24 Sep 2020
AstraZeneca boss says transparency key for vaccine
24 September 2020 - The chief executive of AstraZeneca has said the public must trust that multiple regulators will review ...
Posted by Michael Wonder on 24 Sep 2020
Trump claims White House can overrule FDA's attempt to toughen guidelines for coronavirus vaccine
24 September 2020 - President Donald Trump claimed Wednesday that the White House could override the US FDA if the ...
Posted by Michael Wonder on 23 Sep 2020
FDA poised to announce tougher standards for a COVID-19 vaccine that make it unlikely one will be cleared by Election Day
23 September 2020 - The guidance is part of an effort to boost transparency and public trust as polls show many ...
Posted by Michael Wonder on 22 Sep 2020
FDA launches the Digital Health Center of Excellence
22 September 2020 - Today, the U.S. Food and Drug Administration announced it is launching the Digital Health Center of Excellence ...
Posted by Michael Wonder on 21 Sep 2020
You can trust the FDA’s vaccine process
20 September 2020 - The agency can roll out a Covid shot safely, quickly and without bowing to political pressure. ...
Posted by Michael Wonder on 21 Sep 2020
Democratic chairman says White House blocked FDA commissioner from testifying
19 September 2020 - The White House blocked FDA Commissioner Stephen Hahn from testifying before the House panel overseeing the ...