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The FDA warned a Korean manufacturer over significant GMP violations observed during an inspection in March, including its failure to test incoming components. Read More
The FDA flagged Horizon Pharmaceuticals for failure to follow sanitation procedures, insufficient investigations into customer complaints and inadequate reviews of product discrepancies, among other issues. Read More
The FDA issued a warning letter to a Texas drug compounding facility after it failed to resolve problems identified during an inspection, including serious deficiencies in sterile drug processing. Read More
Dr. Reddy’s Laboratories said it will contest a class-action lawsuit by investors who claim the company made false or misleading statements about its quality system. Read More
As research advances into the biological underpinnings of diseases such as cancer, the FDA is expecting to see more drugs providing more data demonstrating survival benefit earlier in product development, Commissioner Scott Gottlieb told lawmakers at a one-year follow-up hearing on the 21st Century Cures Act. Read More
Each drugmaker’s pharmacovigilance master files and qualified person for pharmacovigilance will have to relocate if they are based in the UK. Read More