Blog
RSS FeedPosted by Michael Wonder on 02 Sep 2022
FDA still skeptical of ALS drug ahead of high stakes meeting
3 September 2022 - The U.S. FDA has posted another negative review of a closely watched drug for the deadly neurodegenerative ...
Posted by Michael Wonder on 31 Aug 2022
Reproducibility of real world evidence studies using clinical practice data to inform regulatory and coverage decisions
31 August 2022 - Studies that generate real world evidence on the effects of medical products through analysis of digital data ...
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 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 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 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
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. ...
Posted by Michael Wonder on 18 Aug 2022
FDA label update reflects Bayer’s commitment to providing options for long-acting contraception
18 August 2022 - FDA approves extension of Mirena (levonorgestrel-releasing intrauterine system) 52 mg intrauterine device for up to eight years ...
Posted by Michael Wonder on 17 Aug 2022
Accelerated approval of cancer drugs: no economic reward for drug makers that conduct confirmatory trials
17 August 2022 - The FDA uses expedited approval of drugs to speed the development and assessment of drugs that address ...
Posted by Michael Wonder on 10 Aug 2022
Real-world data can help expedite drug approvals for serious diseases with few options
10 August 2022 - My grandmother was diagnosed with dementia in the early 2000s. We started taking it seriously when she ...
Posted by Michael Wonder on 10 Aug 2022
Overall survival, progression-free survival and tumour response benefit supporting initial US FDA approval and indication extension of new cancer drugs, 2003-2021
10 August 2022 - Clinical trial evidence is routinely evaluated for initial drug approvals, yet the benefit of indication extensions remains ...
Posted by Michael Wonder on 04 Aug 2022
U.S. regulators defend requiring more data on monkeypox drug
4 August 2022 - As U.S. monkeypox cases rise, U.S. health agencies in a medical journal article published on Wednesday ...
Posted by Michael Wonder on 02 Aug 2022
FDA official: patients play an increasing role in rare disease drug development
1 August 2022 - Patients have a critical role in drug development, from identifying unmet medical needs to assessing meaningful ...
Posted by Michael Wonder on 02 Aug 2022
Characteristics of key patents covering recent FDA approved drugs
1 August 2022 - New drugs are protected by patents that block generic competition and allow manufacturers to charge high prices. ...