Blog
RSS FeedPosted by Michael Wonder on 30 Dec 2022
The FDA’s ‘breakthrough’ program for medical devices keeps gaining steam
28 December 2022 - For medical devices in the Breakthrough Devices Program, 2022 has been a breakout year. ...
Posted by Michael Wonder on 29 Dec 2022
Congressional report: US FDA broke own protocols in approving Biogen Alzheimer's drug
29 December 2022 - The US FDA failed to adhere to its own guidance and internal practices during the approval ...
Posted by Michael Wonder on 27 Dec 2022
New FDA guidance explains that Plan B is not an abortion pill
23 December 2022 - The FDA on Friday altered the language attached to emergency contraceptive pills to clarify that they ...
Posted by Michael Wonder on 23 Dec 2022
FDA’s new real world evidence program offers early agency feedback
21 December 2022 - The US FDA is aiming to improve the quality of real world evidence used in regulatory ...
Posted by Michael Wonder on 21 Dec 2022
Classifying ageing as a disease could speed FDA drug approvals
21 December 2022 - The FDA considers ageing to be a natural process. This makes it difficult to get FDA approval ...
Posted by Michael Wonder on 18 Dec 2022
Ardelyx provides update on FDA appeal for Xphozah (tenapanor) for the control of serum phosphorus in adult patients with chronic kidney disease on dialysis
16 December 2022 - Ardelyx provided an update regarding the appeal to the complete response letter for the new drug ...
Posted by Michael Wonder on 11 Dec 2022
The FDA struggle to withdraw Makena; problems with the accelerated approval process
8 December 2022 - Hydroxyprogesterone caproate (Makena) is an injectable drug for the prevention of preterm birth, ie, birth prior to ...
Posted by Michael Wonder on 10 Dec 2022
Pre-approval promises to voluntarily withdraw FDA approved drugs
9 December 2022 - The US FDA faces a persistent tension between confidence and speed. ...
Posted by Michael Wonder on 10 Dec 2022
You're cured till you're not: should disease-free survival be used as a regulatory or clinical endpoint for adjuvant therapy of cancer?
9 December 2022 - Recent commentary reviewing the use of biologics or other novel molecules tested in the adjuvant setting for ...
Posted by Michael Wonder on 04 Dec 2022
Statistical approaches to establishing bioequivalence
2 December 2022 - Requirements for submitting bioavailability and bioequivalence data in investigational new drugs, new drug applications, abbreviated new drug ...
Posted by Michael Wonder on 29 Nov 2022
FDA looks to modelling and simulation tools to streamline product reviews
28 November 2022 - The US FDA recently published a report on how it uses modelling and simulation, highlighting the untapped ...
Posted by Michael Wonder on 21 Nov 2022
FDA cancer chief wants quicker ways to pull failed drugs
17 November 2022 - Makena highlights need to make system more nimble. ...
Posted by Michael Wonder on 08 Nov 2022
Omeros Corporation receives decision from FDA on formal dispute resolution request for narsoplimab
8 November 2022 - Decision denies Omeros’ appeal requesting immediate labeling discussions. ...
Posted by Michael Wonder on 07 Nov 2022
US Supreme Court to hear Amgen bid to revive cholesterol drug patents
4 November 2022 - The US Supreme Court on Friday agreed to hear Amgen's bid to revive patents on its ...
Posted by Michael Wonder on 27 Oct 2022
FDA continues to advance medicines for children
27 October 2022 - Increasing the availability of safe and effective medicines for children is a key priority for the US ...