Blog
RSS FeedPosted by Michael Wonder on 04 Jan 2023
Options for CMS drug price negotiations
4 January 2023 - In 2026, the Inflation Reduction Act will allow the Centers for Medicare and Medicaid Services to negotiate ...
Posted by Michael Wonder on 02 Jan 2023
Korea to exclude Australia from new drug pricing reference country list
30 December 2022 - HIRA has decided to leave Australia as a reference country when it sets drug prices next ...
Posted 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 20 Dec 2022
Drug pricing reform in the Inflation Reduction Act: what are the implications? Part 2
15 December 2022 - The Inflation Reduction Act, signed by President Biden on 16 August 2022 is the most substantial drug ...
Posted by Michael Wonder on 19 Dec 2022
Drug pricing reform in the Inflation Reduction Act: what are the implications? Part 1
14 December 2022 - The Inflation Reduction Act, signed by President Biden on 16 August 2022, is the most substantial drug ...
Posted by Michael Wonder on 19 Dec 2022
Draft guidance document on the collection and analysis of disaggregated data in clinical trials: transparency
16 December 2022 - This guidance will help sponsors interpret amendments to the Food and Drug Regulations (regulations) requiring them ...
Posted by Michael Wonder on 19 Dec 2022
Facilitating decentralised clinical trials in the EU
19 December 2022 - The European Commission, the Heads of Medicines Agencies and the EMA have published recommendations that aim to ...
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 ...