Newsletter - July 6, 2023
Off-Label Marketing of Artificial Intelligence Based Software Devices!
In the last 5 years, the FDA has cleared about 120 software-enabled medical devices via the 510k pathway for various indications. A recent study of these discrepancies indicates that manufacturers of such devices might be exploiting a loophole in the current device regulation. A review of the 510k summaries...Read More
How Profitable Are the Rare Pediatric Disease Priority Review Vouchers?
Priority review vouchers (PRVs) are a less discussed incentive from the US government to developers of new drugs for certain diseases. These are hard to get but provide an immediate financial gain to the company securing it. So, can developers design programs aimed specifically at benefiting from them? In the last 14 years... Read More
Off-Label Marketing of Artificial Intelligence Based Software Devices!
In the last 5 years, the FDA has cleared about 120 software-enabled medical devices via the 510k pathway for various indications. A recent study of these discrepancies indicates that manufacturers of such devices might be exploiting a loophole in the current device regulation. A review of the 510k summaries...Read More
How Profitable Are the Rare Pediatric Disease Priority Review Vouchers?
Priority review vouchers (PRVs) are a less discussed incentive from the US government to developers of new drugs for certain diseases. These are hard to get but provide an immediate financial gain to the company securing it. So, can developers design programs aimed specifically at benefiting from them? In the last 14 years... Read More