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Each drugmaker’s pharmacovigilance master files and qualified person for pharmacovigilance will have to relocate if they are based in the UK. Read More
Assessors should include information about the drug substances’ general properties and physical characteristics, plus solubility in solvents involved in manufacturing or cleaning processes. Read More
Pharmathen is seeking damages equal to the amount paid to Lachman, the revenues it would have earned from the ANDA and its research and development costs. Read More
President Trump’s nominee for the next secretary of HHS, former Eli Lilly executive Alex Azar, told the Senate’s health committee Wednesday he agrees prescription drug prices are too high, and would welcome congressional action if appointed to the post. Read More
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The FDA released a draft guidance explaining the circumstances when packages and cases are exempted from certain requirements of the 2013 Drug Supply Chain Security Act. Read More