Day: September 10, 2015

This is the year of drug pricing debate. There are numerous voices to challenge high price charged by manufacturers for life-saving drugs, including introduction of a bill this week in the US Congress to add measures for price control. While political and public opinion appears to be shifting towards reducing the spiraling cost of new … Read more

FDA approval is primarily based on avoiding “false positive” or the Type I error, which means approval of a drug that is ineffective or harmful. FDA review is focused on making sure that all products it approves meet the minimum threshold of being safe and effective. According to a policy paper published by an MIT … Read more