Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 25 Feb 2022
Assessment of public opinion on transparency at the US Food and Drug Administration
18 February 2022 - Historically, the US FDA has considered much of the oversight of clinical trials, interactions with companies, and ...
Posted by Michael Wonder on 25 Feb 2022
Updating the Bayh-Dole Act; march-in rights and transparency
24 February 2022 - The Patent and Trademark Law Amendments Act (Bayh-Dole Act [35 USC §200-212]) was enacted in 1980 and ...
Posted by Michael Wonder on 19 Feb 2022
FDA eyes second COVID-19 booster shot
19 February 2022 - The agency has begun reviewing data that could lead to clearing a second booster dose of ...