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STAT Plus: Can a small drug maker make amends with the FDA after giving its inspectors the bum’s rush?




Sometimes, small companies can give regulators the biggest headaches.

Take Immunomedics (IMMU). Last August, executives at the aspiring drug maker locked horns with investigators from the Food and Drug Administration, who sought to examine records pertaining to a quality-control problem at a company facility, but were denied access to all of the records. Why? The company cited attorney-client privilege.

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