Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 25 Oct 2022
FDA panel vote highlights accelerated approval concerns
25 October 2022 - Last week’s overwhelming vote in favour of pulling preterm-birth drug Makena from the market — and ...
Posted by Michael Wonder on 20 Oct 2022
What the Makena vote means about accelerated approval, trust, and the FDA
19 October 2022 - On Wednesday, the FDA advisory committee that oversees obstetrics, reproductive, and urologic drugs voted 14-1 that ...
Posted by Michael Wonder on 20 Oct 2022
How digital health innovators can successfully navigate evolving FDA regulations
19 October 2022 - In the rapidly changing landscape of digital health, innovation has often outpaced regulations, especially for novel ...
Posted by Michael Wonder on 19 Oct 2022
Advancing real world evidence program
19 October 2022 - As announced in the Federal Register notice published on 20 October 2022, the FDA is conducting an ...
Posted by Michael Wonder on 18 Oct 2022
IntelGenx submits response to CRL from FDA for Rizaport VersaFilm
18 October 2022 - IntelGenx today announced that it has responded to the complete response letter for its 505(b)(2) new ...
Posted by Michael Wonder on 17 Oct 2022
FDA pushes to remove pregnancy drug, company pushes back
18 October 2022 - The maker of a drug intended to reduce premature births is making a last-ditch effort to keep ...
Posted by Michael Wonder on 16 Oct 2022
Battle over pregnancy drug highlights risks of FDA expediting drugs to market
16 October 2022 - The year's long effort to yank the drug's approval offers a case study of the agency's accelerated ...
Posted by Michael Wonder on 15 Oct 2022
Gottlieb, McClellan push for FDA regulatory reforms
14 October 2022 - The decision by law makers to drop regulatory reforms of dietary supplements, cosmetics and diagnostic tests from ...