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FDA’s Initial Team-Based Inspection Pilot Deemed SuccessThe pilot helped investigators plan better inspections. Read More BMS to Pay $14 Million in Settlement With SECThe SEC said BMS violated the Foreign Corrupt Practices Act, reaping more than $11 million. Read More TPP Allows Five to Eight Years of Marketing Exclusivity for BiologicsU.S. trade negotiators had sought 12 years of exclusivity. Read More FDA to Approve Generics Based on Proposed LabelingThe FDA will sign off on ANDAs without having to see the print version. Read More FDA Issues Alert After Calif. Pharmacy Refuses to Recall Sterile DrugsAn FDA site inspection found numerous issues with sterile controls. Read More |