While the number of new molecular entities (NME) filed in 2013 (a subset of all NDAs filed) was lower than in 2012 (36 vs 41), there are some interesting facts associated with how CDER did on approvals. For instance, of the 36 NMEs filed in 2013, FDA approved 27. This compares with 39 of the 41 submitted in 2013.
In a blog post on August 12, 2014, I raised the question of why there have been so many recalls of parenteral products related to visible particulate matter. There are a multitude of factors that lead to the formation of particulate matter, some of which have to do with formulation, some with storage, some with handling, some with manufacturing equipment and the like as was discussed in the blog referenced above.
