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Executive Summary

ANDA REVIEW BY FDA FIELD OFFICE CHEMISTS is currently being performed on an experimental basis, FDA Mid-Atlantic Region Director Richard Davis said at a Non-prescription Drug Manufacturers Association manufacturing and controls seminar in Philadelphia on Oct. 4. The trial program provides for the farming out of ANDA submissions by the Center for Drug Evaluation and Research to chemists in the agency's field offices. The program has been submitted by FDA's Field Drug and Biologics Committee for headquarters evaluation. Nine applications are currently being reviewed in the field under the new initiative. The pilot program is part of the agency's response to the application backlog at the Division of Generic Drugs. As such, it parallels another recently announced plan calling for NDA review chemists to assist the generics division in reviewing ANDAs ("The Pink Sheet" Sept. 24, p.2). Davis noted that FDA has recently added more than 50 chemists to its field staff, and these new chemists are being trained in both application review and inspection auditing practices. Under the six-month-old pre-approval inspection program, field chemists frequently have been accompanying investigators in on-site auditing of new applications. Davis said the field drug committee will be proposing new procedures for field participation in review of supplemental applications. The proposed procedures being considered, Davis said, involve field review of GMP-related supplements covering areas such as changes in equipment and personnel, and validation. "We will be working with the center to get something in print" covering the new procedures in the near future, he noted. The implementation of the Prescription Drug Marketing Act is another area getting increased field attention, Davis said. He reported that field offices are seeing a large number of reports of lost samples, adding that "a thick stack of reports" was recently submitted to the Mid-Atlantic Region office for review. Davis said that the agency is continuing to work with states in establishing procedures for certifying drug wholesalers. Davis added that the agency will also be refocusing attention on the labeling area, given the overall high level of recalls and an upsurge in Class I (most serious) labeling recalls over the past year. FDA Compliance Office staffer Tony Lord presented data to the NDMA meeting on labeling recalls for the most recent fiscal year, which ended Sept. 30. There were a total of 48 labeling-related recalls, representing 28% of all recalls for the year, Lord noted. Four Class I recalls appeared on FDA lists during fiscal 1990; an additional one occurred in September that will be listed in fiscal 1991. Recalls attributed specifically to label mix-ups continued their downward trend in 1990, from a peak of 25 in 1988 to eight. However, Lord noted an opposite trend in both product mix-up and printing errors, the latter increasing threefold, from five in 1989 to 15 in 1990. Lord stated that as a result, FDA "will be looking hard to get a grip on product mix-ups and printing errors."

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