Newsletter - November 05, 2015
Tobacco Regulation on Steroids!! FDA Comes Down Hard on Tobacco Retailers
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 CBER. And these 331 Warning Letters only apply to tobacco product companies. Read More..
Want to Know What Trials Supported FDA Approval? Look No Further.
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 Trials Snapshot which provides an easy to review summary of clinical trials for drugs approved in the last 2 years. Read More..
Tobacco Regulation on Steroids!! FDA Comes Down Hard on Tobacco Retailers
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 CBER. And these 331 Warning Letters only apply to tobacco product companies. Read More..
Want to Know What Trials Supported FDA Approval? Look No Further.
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 Trials Snapshot which provides an easy to review summary of clinical trials for drugs approved in the last 2 years. Read More..
