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FDA’s Initial Team-Based Inspection Pilot Deemed Success

The pilot helped investigators plan better inspections. Read More

BMS to Pay $14 Million in Settlement With SEC

The 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 Biologics

U.S. trade negotiators had sought 12 years of exclusivity. Read More

FDA to Approve Generics Based on Proposed Labeling

The 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 Drugs

An FDA site inspection found numerous issues with sterile controls. Read More