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Almost a year after Bayer settled pay-for-delay allegations involving its antibiotic Cipro, Ireland-based Allergan and France-based Sanofi units have struck deals to resolve lingering Cipro claims in ongoing class action litigation, agreeing to pony up $100 million. Read More
Lima & Pergher Industria failed to provide stability data to ensure its drug products’ expiration dates and did not perform microbiological testing on each finished product, the FDA said in a warning letter to the Brazilian company. Read More
The EMA is trying to simplify data integrity compliance by compiling all of its expectations into a single document that covers the entire data integrity lifecycle. Read More
After the EMA issued a report on its adaptive pathway, a German agency took the agency to task for leaving stakeholders in the dark on real-world evidence use. Read More
Drug sponsors that have falsified data will face three years of probation before being allowed to refile marketing applications, the Chinese FDA says. Read More
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has effectively banned products from a Pfizer plant in India after a joint inspection by the FDA, MHRA, Australia’s Therapeutic Goods Administration and Health Canada, the first joint investigation by the four agencies. Read More
When planning an international clinical trial, setting endpoints that are clinically meaningful across regions and planning ahead for local factors are recommended in draft FDA guidance. Read More
After the FDA tackled compliance with international standards for restricting elemental impurities in finished drugs, the EMA has issued guidance on the same topic. Read More