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The Office of Prescription Drug Promotion issued a warning letter to Shionogi, for omitting risks and material facts, for its head-lice lotion Ulesfia in a patient co-pay assistance voucher. Read More
British authorities say serious GMP deficiencies continue to plague Rusan Pharma’s Gujarat manufacturing facility, prompting them to reject all drugs from that site until it is compliant. Read More
The European Medicines Agency is recommending that sponsors use clinical trial information from adults to support the development of therapies for children. Read More
The European Medicines Agency and the European Commission published new track-and-trace safety requirements affecting all drugmakers doing business in EU countries. Read More