Newsletter - November 15, 2018
In the Age of RTT, FDA Struggles to Keep Its Compassionate Use Program Alive
Last week FDA announced new ways to strengthen its expanded access program and, in the process, highlighted what an uphill task is has due to competition from the Right-To-Try (RTT) law. FDA released an updated webpage dedicated to the Expanded Access Program...Read More
Amarin Struggles Show Why Choice of The Right Placebo is Critical
Last week Amarin announced the results of its large Phase 3 with the fish oil product, Vascepa. The trial showed remarkable improvement in cardiovascular events compared to placebo, however, patients on placebo showed higher than normal incidence rate for the same events that Vascepa is supposed...Read More
In the Age of RTT, FDA Struggles to Keep Its Compassionate Use Program Alive
Last week FDA announced new ways to strengthen its expanded access program and, in the process, highlighted what an uphill task is has due to competition from the Right-To-Try (RTT) law. FDA released an updated webpage dedicated to the Expanded Access Program...Read More
Amarin Struggles Show Why Choice of The Right Placebo is Critical
Last week Amarin announced the results of its large Phase 3 with the fish oil product, Vascepa. The trial showed remarkable improvement in cardiovascular events compared to placebo, however, patients on placebo showed higher than normal incidence rate for the same events that Vascepa is supposed...Read More
