Day: July 6, 2023

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, there have … Read more

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 and the subsequent marketing information of … Read more