How long does FDA take to render its decision on whether or not to switch a product?
The truth is that there is no easy answer to this question. While drug user-fee schedules do apply, each case is handled on its own merits and actually may take longer than the predetermined 10-month targeted timeframe. There are a number of reasons that the approval process may be delayed. For example, FDA may ask a manufacturer to provide additional data on the safety, effectiveness, or use of the product. The agency also may ask a manufacturer to modify a product’s labeling so that it is more understandable. Again, the important thing to remember is that each switch application is considered on its own merits.
