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China’s State Medical Insurance Administration approved 17 cancer drugs for inclusion in the country’s national health insurance system with deeply discounted prices. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is seeking industry feedback on a potential no-deal Brexit scenario in which the agency would function as a medicine and medical device regulator on its own. Read More
The European Medicines Agency entered the third phase of its plan to keep industry gears moving while the agency prepares for the UK’s exit from the EU, and said it will temporarily reduce or suspend more activities to save resources. Read More
The European Medicines Agency wants to develop a common data model (CDM) to help speed Europe’s drug development and it’s looking for a hybrid because no current system can answer all the questions posed by the product life cycle. Read More
The FDA issued draft guidance that outlines what the agency considers an ideal and robust verification system that’s also in line with legislative requirements. Read More
International regulators need to take action to reverse the steep decline in research and development for antibiotics, according to the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Read More
Piggybacking on a petition from Pfizer, Novartis called on the FDA to debunk common myths about biosimilars and better educate consumers about their safety and efficacy. Read More
FDA Commissioner Scott Gottlieb said the agency is committed to ensuring “timely completion” of post-marketing studies by drug sponsors in a Friday statement about the agency’s latest report on the status of reviews. Read More
The agency is considering assessing the orphan designation at the marketing authorization stage to encourage applications for rare disease treatments. Read More