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Medicare and its beneficiaries would face significantly lower costs for drugs if the Centers for Medicare and Medicaid Services excluded noncovered versions of drugs while setting Part B drug payments, according to the HHS Office of Inspector General. Read More
The UK government announced a long-term strategy for the nation’s industries, including a multi-billion pound initiative to boost investment in the life sciences sector. Read More
The European Medicines Agency published new, practical guidance for marketing authorization holders in navigating the UK’s 2019 departure from the European Union — including the procedures for classifying any Brexit-related impacts on pharmaceutical manufacturing. Read More
The FDA is working to develop and finalize a handful of new guidances on bringing complex generics to market — including complicated medicines that may require alternate methods of establishing bioequivalence, as well as drug-device combination products that may be blocked by iterative patents. Read More
The FDA flagged Horizon Pharmaceuticals for failure to follow sanitation procedures, insufficient investigations into customer complaints and inadequate reviews of product discrepancies, among other issues. Read More
The European Commission released new GMP guidelines for manufacturers of advanced therapy medicinal products that adapts existing European Union GMP guidelines to the specific characteristics of ATMPs and calls for a risk-based approach. Read More
An Ohio federal judge denied a new trial to plaintiffs in a lawsuit against Abbott Laboratories who claimed their son was born with birth defects because the company failed to warn of the risks associated with its anticonvulsant drug Depakote. Read More