Blog
RSS FeedPosted by Michael Wonder on 30 Aug 2022
TGA launches new look website
30 August 2022 - The new look website has gone live this evening. ...
Posted by Michael Wonder on 29 Aug 2022
FDA boldly bows to big pharma at Americans’ expense
29 August 2022 - A Wall Street Journal headline went this way: “Latest Covid Boosters Are Set to Roll Out ...
Posted by Michael Wonder on 26 Aug 2022
Patient registries: EMA officials highlight opportunities in orphan drug development
25 August 2022 - Officials from the EMA tout the benefits of patient registries to support regulatory decision making for ...
Posted by Michael Wonder on 25 Aug 2022
The failed promise of the US’s Inflation Reduction Act for patients with diabetes
25 August 2022 - Five years ago, I wrote an article for The BMJ describing the struggles I’ve experienced in trying ...
Posted by Michael Wonder on 24 Aug 2022
Prescription medicines: applications under evaluation
24 August 2022 - The TGA has updated its list of applications for new medicines or new uses for existing ...
Posted by Michael Wonder on 24 Aug 2022
How a long-overlooked protein could remake neuroscience drug discovery — or plunge the FDA into controversy
24 August 2022 - So, imagine you get punched in the head. Not once, but a bunch of times. ...
Posted by Michael Wonder on 23 Aug 2022
Hiring and data: how the US will set up new Medicare drug price talks
23 August 2022 - The US Government will soon begin hiring experts and collecting the data needed to launch direct ...
Posted by Michael Wonder on 23 Aug 2022
AstraZeneca's Soriot warns new US drug price law will hurt innovation
23 August 2022 - AstraZeneca's Chief Executive Pascal Soriot warned on Tuesday new US legislation capping drug prices would reduce ...
Posted by Michael Wonder on 22 Aug 2022
The FDA and the clinical community
22 August 2022 - The US FDA preserves and protects the public health through the regulation of food, cosmetics, animal health ...
Posted by Michael Wonder on 22 Aug 2022
Drug pricing reforms can hurt innovation. Here are 3 ways to prevent that.
22 August 2022 - Giving billions of dollars in government prize money to drug companies might sound like an idea from ...
Posted by Michael Wonder on 20 Aug 2022
Pharma’s likely to sue over Medicare negotiation. Here are the arguments they might use.
18 August 2022 - Democrats finally achieved a win over the pharmaceutical industry this month when they passed the most ...
Posted by Michael Wonder on 20 Aug 2022
Improving the use of FDA Advisory Committees
20 August 2022 - Advisory committees cannot support public trust in FDA decisions if the agency uses them inconsistently. ...
Posted by Michael Wonder on 20 Aug 2022
New reforms to prescription drug pricing in the US: opportunities and challenges
19 August 2022 - After several failed legislative efforts over the past decade, in August 2022, Congress enacted prescription drug pricing ...
Posted by Michael Wonder on 20 Aug 2022
Regulatory considerations to keep pace with innovation in digital health products
19 August 2022 - Rapid innovation and proliferation of software as a medical device have accelerated the clinical use of digital ...
Posted by Michael Wonder on 18 Aug 2022
Stability of changes in health status: next step in comprehensively assessing patient reported outcomes
18 August 2022 - Chronic diseases can impair patients’ health status due to symptoms, functional limitations, and impaired quality of life. ...