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Pfizer and Flynn Pharma have appealed a £84.2 million (US $112.5 million) fine from UK’s Competitions and Market Authority over the price of the anti-epilepsy phenytoin sodium capsules, contending the agency misevaluated their positions in the market and mischaracterized the price as “excessive.” Read More
China’s State Council is ordering the China Food and Drug Administration, and other agencies, to implement stricter policies to reform the country’s regulation of drug prices, GMP compliance and pharmaceutical marketing. Read More
The drug and device industries must be prepared for sweeping changes to the status quo promised by the 21st Century Cures Act, according to one expert. Read More
In its latest biennial report to Congress on high-risk government programs, the GAO downgraded its rating of the FDA’s action plans, saying CDER, CBER and CDRH’s long-term strategies lack adequate details and performance measures. Read More