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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

Steve Bunk

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...

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