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A Texas drug compounder is recalling all lots of its sterile drug products after an FDA inspection found it had not investigated failed sterility tests. Read More
Heritage Pharmaceuticals has been hit with a warning letter for what the FDA calls “serious violations” of postmarket reporting requirements. Read More
The European Medicines Agency’s EudraVigilance system for monitoring drug side effects and adverse events is about to undergo an overhaul, and regulators are readying drugmakers and national authorities with a new change plan. Read More
The Washington Legal Foundation is asking the Supreme Court to revisit its stance on drugmakers’ liability in state tort suits over FDA-approved labeling. Read More
A Texas drug compounder is recalling all lots of its sterile drug products after an FDA inspection found it had not investigated failed sterility tests. Read More
Hospira is voluntarily recalling more than 24,000 syringes of the injectable Amidate because out-of-specification results for degraded product were confirmed during stability testing. Read More