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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The FDA issued draft guidance that outlines what the agency considers an ideal and robust verification system that’s also in line with legislative requirements.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
The FDA hit Guadalajara, Jalisco-based drug manufacturer Jabones y Productos Especializados (Soaps and Specialized Products) with a Form 483 for multiple violations, including serious quality deficiencies, observed during a March 20-23 inspection. 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 FDA added immediate-release opioids to its risk evaluation and mitigation strategy (REMS) for opioid analgesics, saying the move will encourage “rational prescribing.” Read More
FDA guidance on submitting field alert reports contradicts federal regulations on the time frame for when reports must be submitted, Perrigo and GlaxoSmithKline said in public comments. Read More