Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 19 Feb 2022
FDA’s Califf shares priority list with agency staff
18 February 2022 - Combatting misinformation about science and responding to the ongoing COVID-19 pandemic are the top priorities for ...
Posted by Michael Wonder on 17 Feb 2022
Dr. Robert Califf returns as FDA's Commissioner
17 February 2022 - The Stakeholder Engagement Staff is pleased to announce the swearing in of Dr. Robert Califf this afternoon, ...
Posted by Michael Wonder on 16 Feb 2022
3D printing medical devices: stakeholders weigh in on FDA’s discussion paper
15 February 2022 - The US FDA has started thinking about how 3D printing of medical devices at the point ...
Posted by Michael Wonder on 15 Feb 2022
Office of Generic Drugs 2021 Annual Report
14 February 2022 - Ensuring high quality, affordable generic drugs are available to the American public. ...
Posted by Michael Wonder on 15 Feb 2022
Biogen Alzheimer drug row augers flux in fast FDA approvals
14 February 2022 - Lawmakers could revamp the fast-track FDA process used to approve Biogen’s Alzheimer’s drug under must-pass legislation ...
Posted by Michael Wonder on 15 Feb 2022
Senate confirms Califf as FDA chief in tight vote
15 February 2022 - The narrow 50-46 decision underscored the divisions on both sides of the aisle over agency policies on ...
Posted by Michael Wonder on 15 Feb 2022
With no votes to spare, Senate advances Califf’s FDA nomination toward final vote
14 February 2022 - In a dramatically close procedural vote Monday night, the Senate voted 49-45 to advance Robert Califf’s ...