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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
The EMA completed all inspections and scientific advice procedures on time and met its performance targets in the first half of 2016 even as GMP inspection requests and orphan designation applications rose, according to a newly released report. Read More
Novartis and the Association for Accessible Medicines, formerly known as GPhA, are criticizing the FDA for underestimating the effect that using random suffixes to identify biologics and biosimilars will have on drugmakers, the market and pharmacovigilance. Read More