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The European Medicines Agency has issued revised guidelines that aim to ease overly burdensome postmarket monitoring and reporting requirements under the EU’s 2010 good pharmacovigilance practices (GVP) regulations. Read More
A federal judge has tossed out all claims brought against Pfizer and Ranbaxy by retailers and distributors in a larger lawsuit that alleges the two companies colluded to delay a generic version of Pfizer’s blockbuster cholesterol drug Lipitor. Read More
Seven generics firms are set to begin distributing licensed versions of Gilead’s blockbuster hepatitis C drug Sovaldi in 91 developing countries, as part of a deal to expand access to the expensive therapy. Read More
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