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A majority of patent settlements reached last year in the European Union restricted the market entry of generics, according to a European Commission report. Read More
The FDA plans to require risk evaluation and mitigation strategies for opioid analgesics — including immediate, extended-release and long-acting formulations — to ensure the benefits outweigh the risks of misuse, abuse, addiction, overdose and death. Read More
Spain’s Agency of Medicines and Medical Devices has ordered Madrid vaccine maker Angulema to suspend manufacturing and recall drug batches over GMP deficiencies. Read More
The Justice Department recovered $4.7 billion in False Claims Act settlements, with the largest recoveries coming from the life sciences industry at $1.2 billion in the last fiscal year. 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 Association of the British Pharmaceutical Industry found five drugmakers — AstraZeneca, Eli Lilly, Janssen, Boehringer Ingelheim and Grünenthal — violated the trade group’s code of practice by engaging in activities that ranged from deceptive marketing to imprecise training. 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
The European Medicines Agency is reviewing data related to studies performed by Micro Therapeutic Research Labs at two sites in India, following a clinical practice inspection. Read More
The FDA finalized guidance on suspect products and notification, describing when to file a report and adding examples of fraudulent activity that would warrant an alert to the agency, trading partners and wholesale distributors. Read More
The FDA intends to publish a proposed rule that would replace current requirements for reports submitted on IND applications, according to an HHS inventory of agency rulemaking for 2017. Read More