FDA Chief Suggests Looking Outside Pharma For Tips On Quality Systems
FDA Commissioner Andrew von Eschenbach asked a group of medical products industry representatives July 9 to "think outside the box" to identify role models or lessons learned from other industries that could help address the challenges of drug import safety in a global marketplace
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HHS Secretary Leavitt announces plan to move regulators away from reliance on border inspections.
House and Senate Democrats are taking similar approaches in regard to invigorating FDA's ability to oversee foreign manufacturing facilities. But some fundamental differences and Republican concerns suggest that the issue will likely not be resolved until at least the next Congress
Events leading up to the distribution of contaminated heparin will be the focus of hearings tentatively scheduled for April 15 by House Energy & Commerce Oversight and Investigations Subcommittee. A week later, FDA Commissioner Andrew von Eschenbach will be asked to provide scenarios for revamping the agency's foreign drug plant inspection program. Seeking an end to the "unsafe" drug import saga, full committee chairman John Dingell, D-Mich., plans action this year on legislation that would assess annual drug import fees of $300 million to pay for inspection of drug imports (1"The Pink Sheet," Aug. 13, 2007, p. 21)