As is well known, FDA's DDMAC has stubbornly refused to deliver any guidance for industry and for advertisers on what is and is not acceptable in communications on the Internet. Instead, the agency has repeatedly stated that it is not … Continue reading
Just about every conversation about the use of digital and social media with pharmaceutical companies starts at the same point – NO. Even if there is a willingness, Med-Reg intimidates and shuts down the effort in most cases, causing the … Continue reading
Normally here at Eye on FDA, warning and untitled letters are reviewed quarterly. Sometimes, however, one stands out as somewhat extraordinary. So it happens with a warning letter DDMAC issued last week regarding a DVD. The DVD features an interview with … Continue reading
Back in the 1990s when I was working as Policy Director at AIDS Project Los Angeles, I was having trouble getting an appointment with a particular Congressman to discuss proposed cuts to the Housing Opportunities for People with AIDS (HOPWA) … Continue reading
No, it isn't a scientific breakthrough – it is a regulatory breakthrough. Yesterday the FDA approved a new opioid based pain relief medication indicated for use with patients in with cancer who experience breakthrough pain who have developed a level … Continue reading
