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 two tomes bound in heavy stock. These, he says, represent just over one volume of a typical application that runs to 150 volumes. Multiple copies are made of each application, he points out. "If you're ever at FDA headquarters in Rockville [Md.] to see a delivery truck come in, you'll know what I mean." The FDA Modernization Act (FDAMA) of 1997, signed into law last November, provides funds for electronic applications, but the agency's district outposts will keep receiving ...
Can FDA Reform Drug Reviews?
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
Written bySteve Bunk
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