Blog
RSS FeedPosted by Michael Wonder on 13 Dec 2024
CDER establishes new Center for Real World Evidence Innovation
12 December 2024 - Today, the US FDA’s Center for Drug Evaluation and Research (CDER) announced the new CDER Center ...
Posted by Michael Wonder on 08 Dec 2024
Autopsy of a drug withdrawal — the case of melphalan flufenamide
7 December 2024 - The accelerated approval pathway, which was established in 1992, has expedited approvals of drugs for serious and ...
Posted by Michael Wonder on 05 Dec 2024
Clearing dense drug patent thickets
27 November 2024 - Proposed reforms from the US Patent and Trademark Office and Congress could work in tandem to prevent ...
Posted by Michael Wonder on 03 Dec 2024
Preferences for speed of access versus certainty of the survival benefit of new cancer drugs: a discrete choice experiment
18 November 2024 - The extent to which patients with cancer are willing to accept uncertainty about the clinical benefit of ...
Posted by Michael Wonder on 03 Dec 2024
The trade-off between accelerated cancer drug approvals and patient preferences
18 November 2024 - Cancer care stands at a critical juncture where the urgency of rapid drug approvals must be balanced ...
Posted by Michael Wonder on 02 Dec 2024
‘We dodged a bullet’: biotech and pharma react to selection of Marty Makary for FDA commissioner
23 November 2024 - Many appear cautiously optimistic about Trump’s intended pick. ...
Posted by Michael Wonder on 21 Oct 2024
Gilead provides update on US indication for Trodelvy in metastatic urothelial cancer
18 October 2024 - Gilead Sciences today announced plans to voluntarily withdraw the US accelerated approval for Trodelvy (sacituzumab govitecan-hziy) for ...
Posted by Michael Wonder on 17 Oct 2024
The science of biosimilars - updating interchangeability
18 October 2024 - Almost 15 years ago the US FDA was given the authority to approve biosimilars through the ...
Posted by Michael Wonder on 07 Oct 2024
Confirmatory trials of accelerated approval drugs — will imposing fines reduce delays?
5 October 2024 - In 1992, patient advocacy groups convinced the FDA to develop an accelerated approval program, which allowed new ...
Posted by Michael Wonder on 21 Sep 2024
Voucher program notches win as clock ticks
20 September 2024 - The FDA’s priority review voucher program for rare paediatric diseases is set to lapse on 30 September ...
Posted by Michael Wonder on 18 Sep 2024
Oncology accelerated approvals are often based on non-comparative trials evaluating response rate
17 September 2024 - Most oncology products granted accelerated approval by the US FDA tend to rely on non-comparative single ...
Posted by Michael Wonder on 16 Sep 2024
The sense and sensibility of sensitivity analyses
14 September 2024 - Clinicians and public health officials routinely make evidence-based decisions that affect patient and population level health. ...
Posted by Michael Wonder on 05 Sep 2024
Breakthrough therapies approved based on surrogate endpoints often lack post-marketing requirements
4 September 2024 - The use of surrogate markers to support drug approvals without requiring postmarketing studies can “hinder accurate ...
Posted by Michael Wonder on 14 Aug 2024
The FDA should withdraw approval of more than 400 tainted medicines
12 August 2024 - When the FDA learned that a testing facility in India had submitted fraudulent data for more ...
Posted by Michael Wonder on 04 Aug 2024
Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy
1 August 2024 - Over the past decades, US Congress enabled the US FDA to facilitate and expedite drug development for ...