Steve Bunk | Mar 15, 1998 | 8 min read
Date: March 16, 1998 New Drug Development A regional lab visit highlights challenges of agency-wide change At the Food and Drug Administration's Central Region office in Philadelphia, cabinetsful of documentation offer only a vague notion of the paperwork involved in getting a new drug through FDA's review and approval process. Nicholas Falcone, the district office's coordinator of new drug applications (NDAs) and abbreviated new drug applications (ANDAs)-the latter for generic compounds-hefts