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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The FDA released a draft guidance explaining the circumstances when packages and cases are exempted from certain requirements of the 2013 Drug Supply Chain Security Act.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
Type IB variations must be notified to the relevant national authorities or the EMA prior to implementation but they are not subject to formal approval. Read More
The Hatch-Waxman Act did not strike a good balance between generic access and brand-name innovation, according to public comments to the FDA from both PhRMA and the Association for Accessible Medicines — however the two groups disagree as to how. Read More