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Punishments for falsification of medicines in the European Union vary significantly between EU member states, according to a study carried out for the European Commission. Read More
Australia’s Therapeutic Goods Administration issued a survey to drugmakers asking about their pharmacovigilance activities with the intention of using the responses to prioritize inspections. Read More
A European Union court ruled that the European Medicines Agency can offer access to clinical trial data in a blow to three drugmakers who argued this would hurt their business. Read More
The FDA flagged a problem with contaminated vial stoppers in a warning letter to Celltrion over deficiencies at its Incheon, South Korea facility, which manufactures Inflectra (infliximab-dyyb), the Ramicade biosimilar. Read More
The FDA hit Nexgen Pharma with a Form 483 after an inspection of its Irvine, California facility revealed procedural and documentation issues. Read More
CDER denied a fourth petition from United Therapeutics calling on the center to impose additional conditions before approving ANDAs for combination products that reference its pulmonary arterial hypertension drug Tyvaso unless they meet specific conditions and measured up to the original in terms of performance and bioequivalence. Read More
Three insurers sued Pfizer to stay off the hook for a $400 million settlement reached by the drugmaker over off-label marketing, claiming the relevant policies had expired. Read More