According to the Pink Sheet, Ann Witt a former Acting Director of DDMAC (or its predecessor organization, I can’t remember the name) is returning to the FDA in CDER’s Office of Policy, Planning and Budget. Ms. Witt was a key staffer for Waxman, who you might recall very vocally questioned the substance and guidance making [...]
In an untitled letter dated April 16, 2009, FDA’s Division of Drug Marketing, Advertising and Communications warned Sanofi Aventis about what it alleges are unsubstantiated claims about the oncology product Taxotere on a reprint carrier. The letter includes fairly common objections of unsubstantiated superiority claims and overstatements of efficacy. For those of us practiced in the [...]
It’s not lost on me that I’ve been taking a long time to get through my analysis of the Good Reprint Practices guidance. My first problem is that I’m busy with other things, which in most cases, is a really good thing. My second problem is that I sometimes go on fantastic voyages into the [...]
Now it could be that you think I’ve gone mad. What does Apocalypse Now, the legendary Francis Ford Coppola movie, have to do with Good Reprint Practices? Does it have something to do with some theme about rebellion, surfing in war zones, madness itself, some parallel to the deterioration of Marlon Brando or to the [...]
So…you may be sitting there trying to put together your thinking about FDA’s final guidance document. You may be thinking about whether or not (or how) to put together a company policy or process in light of FDA’s guidance document. One day you’re a college freshman sitting in the Thurston Howell III Memorial Library planning [...]