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Six pharmaceutical companies are pushing for the dismissal of a False Claims Act suit by the City of Chicago over their promotion of opioids, arguing that the city has yet to provide factual evidence of any harm. Read More
UK’s antitrust agency has accused Actavis of breaching competition law by raising the price of generic hydrocortisone tablets for Addison’s disease by more than 12,000 percent since 2008. Read More
During the coming transfer of political power, the FDA will survive major changes despite strong rhetoric and vague promises for reform, said a long-time FDA insider. Read More
Three years after issuing proposed guidance that laid out the FDA’s expectations for quality agreements with contract manufacturers, the agency has firmed up and expanded what drug companies must do to ensure that their agreements with CMOS are clear and enforceable. Read More
Japan’s Pharmaceutical and Medical Devices Agency is joining the ranks of the FDA, the EMA and a few other drug regulators by agreeing to participate in a program that allows the agencies to share GMP inspection plans and results for API manufacturing sites. Read More
The House Freedom Caucus compiled a broad list of over 200 federal regulations that they would like to see President-elect Donald Trump repeal within his first 100 days in office, including an FDA final rule banning 24 drugs from the market for being unsafe or ineffective. Read More