Foreign Drug Inspections Would Be Funded By Registration Fees In Draft Bill
FDA inspections of overseas drug producers would be supported by annual registration fees under a legislative "discussion draft" being circulated by House Energy and Commerce Committee Chairman John Dingell, D-Mich
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Agency asks for stakeholder comments in advance of issuing a proposed rule on its new authority to detain potentially misbranded or adulterated drugs found during inspections, which was among FDASIA-mandated supply chain security improvements.
Part of Baxter's response to its heparin contamination fiasco has been to bring its scientists together to imagine ways counterfeiters could infiltrate its supply chain and how they would be countered
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