During the Q&A after my audioconference yesterday a participant asked if a proposed drug product containing 1 new drug and 2 already approved drugs would be a 505(b)(2). Although she didn’t say so, I assumed that the 2 approved drugs did not belong to her company.
The answer is yes, the inclusion of these 2 already [...]
Archive for May 8th, 2009
505(b)(2) Combination Products
Published May 8th, 2009 in 505(b)(2) Issues and 505(b)(2) Process. 0 CommentsYesterday, 5/7/09, I gave a 60-minute introductory presentation on 505(b)(2) submissions followed by 15 minutes of Q&A on a Thompson-Interactive audioconference. I enjoy the opportunity to reach out into the community to help people better understand the 505(b)(2) drug development process. Like many of these audioconferences/webinars and the like, there is a charge. Camargo doesn’t receive [...]
