The issue of FDA days and non-FDA days in device applications has been one of the sticking points in the current round of user fee negotiations, and the agency's meeting minutes from the Aug. 24 meeting indicate that FDA may be willing to flex on this point. For those who are concerned about the prospects of cobbling together a user fee agreement to present to Congress by January, the development is an important one as it removes a major hurdle, although several remain. (Medical Device Daily) Read More
