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Executive Summary

FDA OFFICE OF GENERIC DRUGS WILL RELOCATE IN THE FALL, from FDA's Parklawn headquarters building to the agency's Metro Park North campus, also in Rockville, Md. Among the reasons given by the agency for the move are the recent upgrading of the division to office level and the associated increase in personnel, including reviewers to cope with the backlog of ANDAs. With the move to Metro Park North, the Office of Generics will be nearer to the Office of Compliance. During hearings before Rep. Dingell's (D-Mich.) House Oversight Subcommittee, FDA had been urged to improve communications between the compliance and generics staff. Several divisions from the Center for Drug Evaluation and Research also will be moving from the headquarters building due to staff expansions or the need to make room for remaining divisions. The Division of Anti-Viral Drug Products will relocate next month to a separate location on Nicholson Lane in south Rockville. The division has been one of the most rapidly growing, adding seven reviewers to its staff in 1989 to become one of the largest review divisions ("The Pink Sheet" March 12, p. 7). The Office of Drug Standards and Division of Drug Advertising and Labeling are scheduled to move by mid-August to Metro Park North. With the change, Drug Standards will join one of the units under its purview, the Division of OTC Drug Evaluation, at Metro Park. Senate Labor & Human Resources Committee ranking Republican member Hatch's (Utah) FDA revitalization bill would consolidate all FDA components to a single campus, a change that FDA has also wanted. The bill cleared the committee in December but has yet to reach the Senate floor for a vote. In the meantime, FDA recently renewed its lease on the Parklawn building for at least five years and is beginning a renovation of the facilities. However, according to the agency, the lease is not binding and should not be an obstacle to any future consolidation of offices.

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