Kim C. Capone
Porzio Bromberg & Newman PC
Articles
The Last Two Years: A Summary of 2014-2015 Office of Prescription Drug Promotion (OPDP) Enforcement and Relevant FDA Guidance
USA - March 1 2016 The past two years have created a bit of uncertainty for life sciences promotional review professionals. With fewer enforcement letters, high-profile…
FDA seeks comments on proposed comparative price information study
USA - May 20 2014 In a notice published in the Federal Register on May 7, 2014, the federal Food and Drug Administration (FDA) is soliciting comments on a proposed…
OPDP Bad Ad Program absent in 2013 and first four months of 2014
USA - April 30 2014 On May 11, 2010, the Division of Drug Marketing, Advertising, and Communications (DDMAC), now the Office of Prescription Drug Promotion (OPDP)…
The Office of Inspector General releases 2014 Work Plan
USA - March 6 2014 The Office of Inspector General (OIG) has released its 2014 Work Plan. The Work Plan summarizes activities OIG plans to pursue with respect to the U…
Distributing scientific and medical publications on unapproved new uses is the subject of revised FDA draft guidance
USA - March 5 2014 On February 28, 2014, the U.S. Food and Drug Administration (FDA) released the revised draft guidance entitled "Distributing Scientific and Medical…
