Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 09 Oct 2022
New federal incentives for diversity in clinical trials
8 October 2022 - In June 2022, the US House of Representatives passed legislation intended to increase the diversity of ...
Posted by Michael Wonder on 07 Oct 2022
Fulfilment of post-market commitments and requirements for new drugs approved by the FDA, 2013-2016
3 October 2022 - Pre-approval trials of investigational drugs have limited duration and size and often exclude certain populations. ...
Posted by Michael Wonder on 07 Oct 2022
The critical role of academic clinical trials in paediatric cancer drug approvals: design, conduct, and fit for purpose data for positive regulatory decisions
6 October 2022 - For decades, academic clinical trials consortia have collaborated to optimise outcomes for childhood cancers through evaluating incremental ...
Posted by Michael Wonder on 04 Oct 2022
Rare disease endpoint advancement pilot program
3 October 2022 - FDA is establishing a Rare Disease Endpoint Advancement (RDEA) Pilot Program to support novel efficacy endpoint development ...
Posted by Michael Wonder on 04 Oct 2022
Split Real Time Application Review (STAR)
3 October 2022 - Under the Prescription Drug User Fee Act (PDUFA) VII Commitment Letter, the FDA is creating the Split ...
Posted by Michael Wonder on 28 Sep 2022
In new guidance, FDA says AI tools to warn of sepsis should be regulated as devices
27 September 2022 - The FDA on Tuesday published a list of artificial intelligence tools that should be regulated as ...
Posted by Michael Wonder on 15 Sep 2022
FDA issues final rule on ‘right to try’ reporting requirements
14 September 2022 - Drug firms that agree to supply investigational medicines under the Right to Try Act must submit ...