Blog
RSS FeedPosted by Michael Wonder on 06 May 2022
Congress moves toward reforming FDA accelerated approvals, but with pharma friendly concessions
4 May 2022 - House lawmakers are moving a little closer toward cracking down on drugmakers that game the FDA’s ...
Posted by Michael Wonder on 12 Apr 2022
It’s time to fix the FDA by breaking it up
11 April 2022 - A new investigation about the agency’s failures underscores the need for a separate agency to keep our ...
Posted by Michael Wonder on 17 Mar 2022
Panel scrutinises quick FDA drug approvals
17 March 2022 - A House committee will spotlight an FDA process that’s been criticised as putting some of the ...
Posted by Michael Wonder on 03 Mar 2022
PRIME enables earlier availability of life-changing medicines
3 March 2022 - EMA’s PRIority Medicines (PRIME) scheme has had a positive impact on the authorisation of new medicines that ...
Posted by Michael Wonder on 15 Feb 2022
Office of Generic Drugs 2021 Annual Report
14 February 2022 - Ensuring high quality, affordable generic drugs are available to the American public. ...
Posted by Michael Wonder on 15 Feb 2022
Human medicines: highlights of 2021
15 February 2022 - In 2021, EMA recommended 92 medicines for marketing authorisation. Of these, 53 had a new active substance ...
Posted by Michael Wonder on 14 Feb 2022
EMA starts safety review of Janus kinase inhibitors for inflammatory disorders
11 February 2022 - EMA’s safety committee, PRAC, has started a review of the safety of Janus kinase (JAK) inhibitors ...
Posted by Michael Wonder on 18 Jan 2022
TGA in review (2021)
19 January 2022 - Using a liberal definition of what constitutes a 'new medicine', we have determined the TGA approved ...
Posted by Michael Wonder on 11 Jan 2022
FDA approved more first in class drugs, gave more accelerated approvals in 2021
7 January 2022 - The US Food and Drug Administration’s Center for Drug Evaluation and Research approved 50 new drug therapies ...
Posted by Michael Wonder on 04 Dec 2021
Reforms needed for FDA’s regulation of medical devices
3 December 2021 - Medical devices are mainstays of modern medicine, from basic products like gloves and bandages to complex ...
Posted by Michael Wonder on 24 Nov 2021
Review of real world evidence and patient reported outcomes
24 November 2021 - The TGA recently commissioned a review into its usage of real world evidence and patient reported ...
Posted by Michael Wonder on 21 Sep 2021
U.S. Food and Drug Administration reasoning in approval decisions when efficacy evidence is borderline (2013–2018)
21 September 2021 - The U.S. FDA has substantial flexibility in its approval criteria in the context of life-threatening disease and ...
Posted by Michael Wonder on 15 Sep 2021
Final report on the Australian Government response to the recommendations of the Senate Community Affairs References Committee Report
15 September 2021 - The Government acknowledges the efforts and actions detailed in this progress report to implement the Senate ...
Posted by Michael Wonder on 13 Aug 2021
Congress should fix FDA’s accelerated approval program for the next 30 years
12 August 2021 - The FDA's approval of the Alzheimer’s drug Aduhelm has sparked a broader debate on the merits ...
Posted by Michael Wonder on 08 Aug 2021
US tropical disease priority review vouchers: lessons in promoting drug development and access
6 August 2021 - The COVID-19 global pandemic has devastated lives and economies. It has served as a reminder of how ...