What’s New
We share news about new product features, our thoughts on recent developments at MedaSystems or in the industry at large. Scroll down for a chronological view, or jump to posts using the categories to the left.
Takeaways from Operationalize Expanded Access Programs 2024
The MedaSystems team reflected on some learnings from the Operationalize Expanded Access Show 2024, from insights into global programs to the importance of efficiency.
Investigational Medicine Access Amid the Oncology Drug Shortage
The healthcare sector worldwide is reeling from a severe shortage of vital cancer drugs, including Carboplatin and Cisplatin, cornerstone therapies in various cancer treatments.
Only 51% of US companies are compliant with Expanded Access visibility laws
According to a recent analysis, only 51% of qualified US drug companies appear to comply with the legal requirements for expanded access visibility fully.
What we’re reading: Q&A on the ethics of ultra-rare disease drug development and expanded access
This week at MedaSystems, we’re thinking about rare diseases and how patients can access treatment through Expanded Access. Read this Q&A on the topic from Clinical Trials Arena and
What we’re reading: NYT “How far do you go when the alternative is death?”
What we’re reading: “How far do you go when the alternative is death?” and article by Daniela J. Lamas in the New York Times, tells the story of a patient requesting expanded access.
How does the FDA view expanded access data?
An overview of the FDA’s approach to real-world data gathered during Expanded Access