Day: November 5, 2015

New drug approval by FDA is based on multiple clinical trials. It has always been hard for consumers to get a summary of all clinical trials conducted in support of a given drug. FDA recently created a tool to summarize the main clinical trials done to seek FDA approval. FDA recently released a web-page called Drug … Read more

Since the passage of the Tobacco Control Act in 2009, FDA’s Office of Tobacco Products (OTP) has been aggressively asserting its authority over all kinds of tobacco products. In its short 5 year life, the OTP has issued more Warning Letters than both CDER and CBER combined. OTP issued 331 Warning Letters to 273 by CDER and a measly 26 by … Read more