Blog
RSS FeedPosted by Michael Wonder on 24 Jul 2024
Jeff Shuren, medical devices head at FDA, to leave the agency
23 July 2024 - Jeffrey Shuren, longtime chief regulator of medical devices at the FDA, announced to staff on Tuesday ...
Posted by Michael Wonder on 24 Jul 2024
This gene therapy may not work. So why did the FDA fully approve it?
22 July 2024 - The agency has repeatedly neglected its obligation to ensure that drugs are effective. ...
Posted by Michael Wonder on 24 Jul 2024
Fixing the reimbursement and coverage divide between ‘breakthrough’ drugs and medical devices
23 July 2024 - The FDA designates as “breakthrough” technologies certain drugs and devices. This designation helps expedite the development and ...
Posted by Michael Wonder on 18 Jul 2024
Transparent and complete reporting of surrogate endpoints in trials: the SPIRIT-Surrogate and CONSORT-Surrogate extensions
11 July 2024 - Randomised trials are resource-intensive studies that provide robust evidence for evaluating the effectiveness of interventions. ...
Posted by Michael Wonder on 03 Jul 2024
Approval of newest Alzheimer’s drug will accelerate new era of treatment
2 July 2024 - With the arrival of Lilly’s Kisunla, Alzheimer’s care could become more like treatment of cancer and rheumatoid ...
Posted by Michael Wonder on 01 Jul 2024
FDA opens doors for more treatments for rare diseases through the new START Pilot Program
27 June 2024 - We are at a turning point in understanding the science that is opening doors to rare disease ...
Posted by Michael Wonder on 01 Jul 2024
Real world evidence submissions to the Center for Biologics Evaluation and Research
26 June 2024 - As part of the reauthorisation of the Prescription Drug User Fee Act (PDUFA VII), FDA committed ...
Posted by Michael Wonder on 30 May 2024
FDA use of “proxies” to expedite drug approvals not supported by evidence, analysis finds
28 May 2024 - In the world of drug development, there has been a recent movement to speed clinical trials of ...
Posted by Michael Wonder on 21 May 2024
Federal Trade Commission actions on prescription drugs (2000-2022)
20 May 2024 - The Federal Trade Commission’s oversight role in the pharmaceutical market is critical to the health of ...
Posted by Michael Wonder on 20 May 2024
Overall survival benefits of cancer drugs initially approved by the US FDA on the basis of immature survival data: a retrospective analysis
13 May 2024 - New cancer drugs can be approved by the US FDA on the basis of surrogate endpoints while ...
Posted by Michael Wonder on 27 Apr 2024
A milestone in facilitating the development of safe and effective biosimilars
26 April 2024 - This week, the FDA approved the 50th biosimilar, reflecting the markedly increased availability of biosimilar products—products that ...
Posted by Michael Wonder on 25 Apr 2024
Bashing accelerated approval isn’t supported by the data
24 April 2024 - The FDA’s accelerated approval program aims to speed “approval of drugs that treat serious conditions, and ...
Posted by Michael Wonder on 23 Apr 2024
Associations between surrogate markers and clinical outcomes for non-oncologic chronic disease treatments
22 April 2024 - What is the strength of association between surrogate markers used as primary outcomes in clinical trials ...
Posted by Michael Wonder on 27 Mar 2024
Patient advocates clash over wisdom of ‘approving drugs faster and faster’
26 March 2024 - Over 30 years ago, Gregg Gonsalves and other AIDS activists persuaded Congress to create the accelerated ...
Posted by Michael Wonder on 28 Feb 2024
The FDA isn’t afraid to yank a disappointing drug
26 February 2024 - The FDA is rescinding its approval of a blood cancer treatment from the Swedish firm Oncopeptides, ...