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FDA DRUG INSPECTION INITIATIVES

This article was originally published in The Gold Sheet

Executive Summary

...include a new pilot program involving pre-announced inspections, annotated FD-483s, and notification of positive audit results. After success with these innovations in the medical device area, field management will test them for drugs beginning in 1999 in an effort to improve FDA/ industry communications. FDA is moving forward with other initiatives to reshape and streamline its drug and biologic inspection programs, including: § § an MRA with the EU § § an internationally harmonized bulk GMP guideline § § guidance on out-of-specification result investigations § § Team Biologics § § investigator certification § § a first party audit program, and § § an effort to focus firms on the year 2000 computer problem.
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