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The FDA has again rejected Amarin’s appeal for the agency to reinstate a special protocol assessment (SPA) on a phase III study of its triglyceride drug Vascepa, a move that casts doubt on the drugmaker’s ability to expand its indication on the fish oil-based product. Read More
Australia’s Department of Health has moved the division overseeing the import and export of certain drugs from the department’s office of chemical safety to the Therapeutic Goods Administration’s office of scientific evaluation as part of a move to better align agency functions. Read More
The drug pricing authority in India is warning manufacturers, importers and marketers of certain essential drugs that they will face legal action if they don’t immediately submit monthly production and sales figures and other compliance documents, as officials try to address the scarcity of products in many parts of the country. Read More
The European Medicines Agency wants to help manufacturers take advantage of its adaptive licensing pilot program, which aims to speed patient access to new treatments via a process that authorizes products for use by targeted populations in stages. Read More
The FDA needs to clarify whether its 10-day ANDA correspondence clock starts ticking once a manufacturer receives the agency’s communication or at the moment the agency mails it, say generics firms, which also urge the FDA to start sending all communications by fax or email. Read More
Countries in the Caribbean are working to establish a unified registration process for generic drugs — an effort aimed at improving the quality and availability of basic medicines. Read More