Teva Rep: FDA Shift From Petitions To Guides Too Slow For Combo Products

FDA's move toward developing more product-specific guidances rather than establishing policy through citizen petition responses may cause delays in agency policy development and leave industry left with unanswered questions, especially in the combination products space, one industry representative argued at a recent conference. FDA, however, argues that combination products are becoming more complex, which calls for the product-specific approach. Brian McCormick, chief regulatory counsel for Teva Pharmaceuticals, said that FDA's shift could leave a void in the policy development process,...