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Your current issue of Alert is attached. To view any individual article, click on a headline.

Seventh Annual FDA Inspections Summit on Sept. 19-21, 2012 in Bethesda, MD. Each year, the FDA makes adjustments to its inspection processes and policies. This year is no exception.Year after year, the crème de la crème of the industry make it their business to attend this conference and tap into the cumulative knowledge of an accomplished group of top officials from CDER, CDRH, CBER, the Office of Regulatory Affairs (and more). Register today to hear about breaking news directly from prominent FDA officials. That's why you can't afford NOT to attend the Seventh Annual FDA Inspections Summit.

  • The Devil You Don’t Know: FDA Issues Enforcement Action Based on Non-FDA Inspection
    PHILADELPHIA — International cooperation between regulators is “taking off” — a trend that could limit the amount of duplicate inspections drugmakers face, a top CDER official says. While “mutual recognition” of inspections is not yet a reality, drugmakers shouldn’t expect the FDA to close its eyes to negative inspection findings from other regulators.

  • Drugmaker Investment in New Manufacturing Plants Is ‘Real Solution’ to Shortages: FDA Official
    PHILADELPHIA — The FDA is calling on drugmakers to build new manufacturing plants as part of their contribution to preventing drug shortages. While early notification from industry has helped the FDA prevent or lessen some shortages, new manufacturing facilities are “the real solution,” CDER’s Office of New Drugs Deputy Director Sandra Kweder says. Many facilities are outdated and there is no idle time to repair them, Kweder added.

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