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www.fdanews.com/articles/120234-report-recommends-changes-for-fda-8217-s-postmarketing-study-review

Report Recommends Changes for FDA’s Postmarketing Study Review

September 4, 2009
Drug and biologic makers are on schedule with most postmarketing clinical trials and studies, but while the FDA misses its review deadlines more than half the time, some criticism of its oversight is undeserved, according to a Booz Allen Hamilton report released at an FDA press briefing last week. The FDA also released its fiscal 2008 annual report that shows 95 percent of the postmarketing requirements for NDAs and ANDAs are on schedule as are 89 percent of BLAs.
Drug Industry Daily