In 2010, the Center for Drug Evaluation and Research’s Division of Drug Marketing, Advertising and Communications (DDMAC) issued a total of 52 enforcement letters to pharmaceutical and biolog...read more
By the time you read this, the Food and Drug Administration (FDA) will have received hundreds of “substantial equivalence” applications from tobacco manufacturers covering all products ...read more
“Is it really possible for FDA to keep up with Steve Jobs?” Jeffrey N. Wasserstein, Director at Hyman, Phelps & McNamara, P.C., asked this as he introduced a panel of social media ...read more
It’s Thursday, April 7th as I am writing this – a little footsore from wearing high heels for the past three days at the 2011 FDLI Annual Conference. Although these types of meetings ca...read more
Tobacco, as a new addition to the realm of FDA regulation, is also new to FDLI. Since President Obama signed the Family Smoking Prevention and Tobacco Control Act, Update and the Food and Drug Law ...read more
Since 2007 and 2009, respectively, oversight of food safety and medical products have been included on the U.S. Government Accountability Office (GAO) high risk list. The GAO, an independent nonpar...read more
“For FDA, innovation is not just about new ideas, but it is about making sure that those new ideas truly translate into the products and opportunities that people need and count on,” Co...read more
“We are making progress,” Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) at FDA, said during her remarks, reflecting on the past year and outlining the C...read more
The cornerstone panel of FDLI’s 2011 Annual Meeting was a roundtable discussion with CEOs of the Food and Drug Administration (FDA) regulated industry. Led by Susan C. Winckler, FDLI’s ...read more
Anecdotal reports of the potential health effects of tobacco consumption date back to at least 1604 with King James’ prescient treatise “A Counterblaste to Tobacco,” which describ...read more