I have addressed this topic before but from several recent discussions I thought it useful to repeat this here.
A number of companies hope to do just BE studies to obtain approval. The proposed changes to the RLD are formulation, dosage form, IR to ER, etc. The sponsor believe or has designed the product to have the [...]
Archive for October, 2008
Just a BE study for 505(b)(2) approval? Likely not!
Published October 24th, 2008 in 505(b)(2) Issues. 0 CommentsCamargo was one of the sponsors of Cambridge Healthtech Institute’s Drug Repositioning Summit last week (Oct. 6-7, 2008). I woke the group up on the second day with a breakfast talk entitled “505(b)(2) Experiences - The Journey Continues”. I reviewed some of the important changes over the last few years that the FDA has made [...]
Sertraline + CBT - a new 505(b)(2) Combo
Published October 31st, 2008 in 505(b)(2) Issues and News Commentary. 0 CommentsSeveral news sources report today (10/31/2008) that a new study shows that sertraline in combination with CBT eases anxiety in children. A number of 505(b)(2) development projects arise from observing these kinds of trials: an efficacy study shows that two (or more) concurrent treatments are safe and effective for a given set of indications. It [...]