Blog
RSS FeedPosted by Michael Wonder on 04 Apr 2023
New features further strengthen Priority Medicines scheme (PRIME)
4 April 2023 - The EMA is introducing a number of new features to the PRIority Medicines (PRIME) scheme to ...
Posted by Michael Wonder on 04 Apr 2023
Medicare non-compliance and fraud costing Australians
4 April 2023 - The Albanese Government has today released the findings of a review into the compliance system that underpins ...
Posted by Michael Wonder on 03 Apr 2023
FDA draft guidance allows AI/ML devices to evolve without requiring new submissions
31 March 2023 - The US FDA published a draft guidance outlining how sponsors of artificial intelligence and machine learning (AI/ML) ...
Posted by Michael Wonder on 02 Apr 2023
Ensuring public trust in an empowered FDA
1 April 2023 - The FDA’s recent approval of lecanemab for Alzheimer’s disease has been clouded by controversy over other accelerated ...
Posted by Michael Wonder on 29 Mar 2023
Medical device companies now need to prove to FDA they’re protected against cyber attacks
29 March 2023 - Hidden in this year’s federal spending bill, among major changes to Medicare payments to doctors and ...
Posted by Michael Wonder on 28 Mar 2023
DARWIN EU has completed its first studies and is calling for new data partners
28 March 2023 - DARWIN EU, the Data Analysis and Real World Interrogation Network, has accomplished its first year of establishment. ...
Posted by Michael Wonder on 28 Mar 2023
iOnctura awarded UK's MHRA Innovation Passport for entry into innovative licensing and access pathway
28 March 2023 - iOnctura today announces that the innovative medicine designation, the Innovation Passport, has been awarded for roginolisib, ...
Posted by Michael Wonder on 27 Mar 2023
Biden says he wants to bring down drug prices. His actions tell a different story.
24 March 2023 - You might get the impression from the Biden administration’s insulin price cut and its initiative allowing ...
Posted by Michael Wonder on 27 Mar 2023
TGA’s new powers will help reduce the impact of medicine shortages on patients
24 March 2023 - From 22 March 2023, the TGA can approve the temporary import or supply of an overseas approved ...
Posted by Michael Wonder on 25 Mar 2023
TLV is preparing for an increase in ceiling prices
17 March 2023 - In order to ensure continued good access to medicines for patients, TLV started in the autumn of ...
Posted by Michael Wonder on 25 Mar 2023
MHRA to streamline clinical trial approvals in biggest overhaul of trial regulation in 20 years
21 March 2023 - The legislative changes will help to make the UK one of the best countries in the world ...
Posted by Michael Wonder on 22 Mar 2023
Advancing regulatory science in the EU – mid-point report published
22 March 2023 - The EMA has published a report summarising the mid-term achievements of its regulatory science strategy to ...
Posted by Michael Wonder on 21 Mar 2023
Top FDA official: agency needs to start using accelerated approval for gene therapies
20 March 2023 - A top FDA official said Monday that the agency needs to start using accelerated approval, a ...
Posted by Michael Wonder on 20 Mar 2023
Opioid settlement hinders patients’ access to a wide array of drugs
13 March 2023 - An agreement between attorneys general and major drug distributors increased scrutiny on medications for ADHD, addiction, anxiety ...
Posted by Michael Wonder on 20 Mar 2023
UK to give “near automatic sign off” for treatments approved by “trusted” regulators
16 March 2023 - The UK Government has announced £10 million funding for the country’s medicines and devices regulator to ...