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To help speed the approval of generics, the FDA said it would not wait for the Federal Register to publish determinations that a reference listed drug’s removal from sale had nothing to do with safety and effectiveness. Read More
Asked if she would push for negotiating drug prices under Medicare as the next CMS administrator, Seema Verma told a Senate committee she couldn’t give a simple “yes or no answer.” Read More
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