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To drive the manufacturing of advanced therapies, industry is asking the European Medicines Agency to provide further guidance, to harmonize EU regulations and to exercise flexibility. Read More
The European Medicines Agency is recommending that drugmakers update their risk management plans when switching to a new manufacturing process for products with centralized marketing authorization. Read More
The federal appellate court has ruled that the Medicines Company’s use of third-party suppliers to manufacture its blood thinner Angiomax does not invalidate the drug’s patents, reversing an earlier panel decision. Read More
The European Union wants to expand ongoing trade talks between the U.S. and EU to address regulatory harmonization on drug approval requirements, guidelines and GMP compliance. Read More
The FDA is advising generic drugmakers looking to revise their labels without the fallback of a reference product that they have only one route: supplemental submissions. Read More
The FDA is laying out compliance parameters for outsourcing facilities that compound near replicas of approved drugs, urging them not to distribute such products to patients that could use an approved drug. Read More