FDA's Advertising Letters Continue To Grow, Both In Volume And Depth
Executive Summary
FDA's Division of Drug Marketing, Advertising and Communication appears to be shifting the way it writes citations to firms, increasing not just the number of letters it sends, but the number of problems it lists within each letter
You may also be interested in...
FDA’s Rx Enforcement Letter Output Drops In 2011; OPDP Sees Improvement In Promotions
The 30 letters issued are the lowest since 2008, but FDA says the number is only part of its enforcement strategy.
"The Pink Sheet" – Most Notable Stories Of 2010
While industry mega-mergers occupied readers in 2009, the focus in 2010 shifted toward several evolving policy concerns and their impact on company strategy. Among these, more companies are looking at the opportunity for biosimilars created by the health care reform law's provision of a legal framework for product approval. But early analyses suggest that there is still a lot of work to do as FDA develops a guideline for industry on an abbreviated approval pathway.
"The Pink Sheet" – Most Notable Stories Of 2010
While industry mega-mergers occupied readers in 2009, the focus in 2010 shifted toward several evolving policy concerns and their impact on company strategy. Among these, more companies are looking at the opportunity for biosimilars created by the health care reform law's provision of a legal framework for product approval. But early analyses suggest that there is still a lot of work to do as FDA develops a guideline for industry on an abbreviated approval pathway.