Blog
RSS FeedPosted by Michael Wonder on 03 Apr 2025
Platform clinical trials for the efficient evaluation of multiple treatments
31 March 2025 - For some medical conditions, including conditions without effective treatments, multiple promising but unproven therapies may exist, with ...
Posted by Michael Wonder on 08 Mar 2025
FDA’s accelerated approval guidance gets pushback from industry
7 March 2025 - The pharmaceutical industry has some questions regarding the US FDA's recent guidance on its accelerated approval ...
Posted by Michael Wonder on 03 Mar 2025
Supporting the development of drugs for rare diseases - the importance of regulatory transparency
1 March 2025 - Transparency regarding the information submitted to the FDA and the agency’s decision making could have far-reaching ...
Posted by Michael Wonder on 17 Feb 2025
Out of pocket getting out of hand - reducing the financial toxicity of rapidly approved drugs
15 February 2025 - In 2023, Teresa was diagnosed with amyotrophic lateral sclerosis. Several months later, her family started a GoFundMe ...
Posted by Michael Wonder on 07 Feb 2025
US FDA approves Emblaveo (aztreonam and avibactam) for the treatment of adults with complicated intra-abdominal infections with limited or no treatment options
7 February 2025 - Emblaveo is the first and only monobactam/β-lactamase inhibitor combination antibiotic therapy approved by the US FDA to ...
Posted by Michael Wonder on 04 Feb 2025
Comparison of clinical evidence submitted to the FDA and EMA for cell and gene therapies
3 February 2025 - Harmonisation in regulatory submissions across agencies may support timelier access to innovative treatments, including cell and gene ...
Posted by Michael Wonder on 28 Jan 2025
Vanda Pharmaceuticals accepts FDA opportunity for a hearing on new drug application for tradipitant in gastroparesis
27 January 2025 - Highlights faulty FDA review. ...
Posted by Michael Wonder on 12 Jan 2025
Vanda's letter to FDA Commissioner highlights faulty gastroparesis NDA review
8 January 2025 - Vanda Pharmaceuticals letter to FDA Commissioner highlights faulty gastroparesis NDA review. ...
Posted by Michael Wonder on 09 Jan 2025
CDER brings many safe and effective therapies to patients and consumers in 2024
8 January 2024 - Each year, the US FSA’s Center for Drug Evaluation and Research (CDER) evaluates and, as appropriate, approves ...
Posted by Michael Wonder on 02 Jan 2025
Save the Food and Drug Administration by breaking it up
2 January 2025 - Let’s separate the FDA into two distinct entities. ...
Posted by Michael Wonder on 13 Dec 2024
CDER establishes new Center for Real World Evidence Innovation
12 December 2024 - Today, the US FDA’s Center for Drug Evaluation and Research (CDER) announced the new CDER Center ...
Posted by Michael Wonder on 08 Dec 2024
Autopsy of a drug withdrawal — the case of melphalan flufenamide
7 December 2024 - The accelerated approval pathway, which was established in 1992, has expedited approvals of drugs for serious and ...
Posted by Michael Wonder on 05 Dec 2024
Clearing dense drug patent thickets
27 November 2024 - Proposed reforms from the US Patent and Trademark Office and Congress could work in tandem to prevent ...
Posted by Michael Wonder on 03 Dec 2024
Preferences for speed of access versus certainty of the survival benefit of new cancer drugs: a discrete choice experiment
18 November 2024 - The extent to which patients with cancer are willing to accept uncertainty about the clinical benefit of ...
Posted by Michael Wonder on 03 Dec 2024
The trade-off between accelerated cancer drug approvals and patient preferences
18 November 2024 - Cancer care stands at a critical juncture where the urgency of rapid drug approvals must be balanced ...