Yikes! For the first time, Camargo has two (yes, 2!) pre-IND meetings denied. Same week. Not cancelled, not postponed, not re-scheduled - denied! In both cases, the review divisions said we were on the right track, no controversy exists and that we should simply file the IND.
Wow. The purpose of the pre-IND meeting is much more [...]
Archive for April 15th, 2008
Is your drug project a 505(b)(2), ANDA or OTC?
Published April 15th, 2008 in How to: and Uncategorized. 0 CommentsI get a lot of requests to assure people that their project is, or is not, a 505(b)(2). A few questions about whether it is an OTC candidate. The question about whether the proposed drug is a 505(b)(1) or 505 (b)(2) is readily answered by the question: is any data essential for approval being obtained [...]
