PROJECT MANAGEMENT SITE TOUR PROGRAM EXTENDED
The FDA's regulatory project managers will continue to tour industry manufacturing
sites in order to give them a better understanding of drugmakers' operations,
the agency said in a recent notice.
The Regulatory Project Management Site Tours Program, initiated in 1999, gives small groups of FDA regulators a chance to interact with drugmakers at their facilities to observe manufacturing, packaging and other aspects of production, the agency said.
The FDA stressed that "neither this tour nor any part of the program is intended as a mechanism to inspect, assess, judge or perform a regulatory function, but is meant rather to improve mutual understanding and to provide an avenue for open dialogue."
Companies wishing to sponsor tours have 60 days to respond with a proposed agenda. To view the notice, published in the Federal Register, go to http://www.fda.gov/OHRMS/DOCKETS/98fr/cd0593-n000001.pdf.