Blog
RSS FeedPosted by Michael Wonder on 06 Apr 2022
U.S. FDA aims to decide on strain selection for COVID boosters by June
6 April 2022 - The U.S. FDA said it is aiming to come up with a decision on coronavirus strain ...
Posted by Michael Wonder on 05 Apr 2022
FDA updates sotrovimab emergency use authorisation
5 April 2022 - Sotrovimab is no longer authorised to treat COVID-19 in any U.S. region due to increases in ...
Posted by Michael Wonder on 05 Apr 2022
Watchdog urged to probe McKinsey over work with FDA, opioid manufacturers
5 April 2022 - The consulting firm was getting paid by opioid makers while working for the FDA. ...
Posted by Michael Wonder on 02 Apr 2022
Califf admits controversy over FDA’s Alzheimer’s drug decision impacted experts’ trust in the agency
31 March 2022 - Robert Califf, the new head of the FDA, admitted Thursday that the agency’s controversial approval of ...
Posted by Michael Wonder on 30 Mar 2022
FDA officials aim to stop misuse of the term ‘digital biomarker’
29 March 2022 - While a lot of researchers claim they are capturing digital biomarker data, they may in fact be ...
Posted by Michael Wonder on 24 Mar 2022
Pressured by patients, FDA reviews ALS drug with modest data
25 March 2022 - The FDA meets next week to review a closely watched drug for ALS, or Lou Gehrig’s ...
Posted by Michael Wonder on 17 Mar 2022
Panel scrutinises quick FDA drug approvals
17 March 2022 - A House committee will spotlight an FDA process that’s been criticised as putting some of the ...
Posted by Michael Wonder on 10 Mar 2022
Legislation would set expiration for FDA’s accelerated approvals
9 March 2022 - New legislation, introduced by a top Democrat in the House of Representatives, would codify the U.S. ...
Posted by Michael Wonder on 10 Mar 2022
When desperate patients go to court for unproven treatments - the battle for hospital independence
9 March 2022 - During the COVID-19 pandemic, patients have asked courts to compel hospitals to administer unproven therapies, including ivermectin. ...
Posted by Michael Wonder on 09 Mar 2022
More Government regulation of biopharma would harm patients and the economy
8 March 2022 - The United States leads the world in creating the new drugs and vaccines that cure or control ...
Posted by Michael Wonder on 08 Mar 2022
FDA effort to improve clinical trial diversity failed to make a difference for Black patients, study finds
7 March 2022 - Six years ago, the U.S. FDA launched a five year action plan to improve the diversity and ...
Posted by Michael Wonder on 08 Mar 2022
FDA offers funding for biosimilar regulatory science pilot
7 March 2022 - The US FDA is offering funding for several research proposals under the regulatory science pilot for ...
Posted by Michael Wonder on 07 Mar 2022
Key Democrat moves to crack down on FDA accelerated approvals
7 March 2022 - A powerful Democratic lawmaker has introduced a bill that would dramatically rein in the Food and ...
Posted by Michael Wonder on 04 Mar 2022
Science hasn’t shown these medications work. They’re being sold anyway.
3 March 2022 - Federal regulators are increasingly approving medicines before studies have shown they work, leaving patients at risk ...
Posted by Michael Wonder on 03 Mar 2022
Digital Therapeutics should be regulated with gold standard evidence
28 February 2022 - There is enormous growth in the digital health sector, illustrated by huge capital investment, and a massive ...