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The International Council for Harmonisation adopted an update to its good clinical practice guideline, recommending approaches to clinical trial design and management, as well as ensuring patient protection and data integrity. The amendment to its E6 guideline will now be implemented by ICH members through national and regional guidance. Read More
House Republicans have asked all federal agencies to postpone rulemaking until President-elect Donald Trump’s administration and the newly elected Congress assume office next year. Read More
The EMA Management Board has advanced the development of a web portal that will provide free information on European medicines across the products’ lifecycle. Read More
The European Medicines Agency is investigating reports that India’s Wanbury Pharma, one of the largest exporters of the diabetes drug metformin, had more than half of its exports produced by an unlicensed supplier. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use is recommending the approval of five new medicines and three generics to treat a range of illnesses from cancer to HIV. Read More
India is giving drugmakers of unapproved combination products more time to justify their manufacturing and marketing of the drug in the country. Read More
The International Council for Harmonization has identified the key scientific issues pediatric drug developers must address early on to improve the prospects for a drug’s approval later in the development process, in a draft that updates a 16-year-old efficacy guideline. Read More
NHS England and the UK’s National Institute for Health and Care Excellence have unveiled a proposal for an abbreviated review process for therapies identified as having exceptional value based on cost and effectiveness. Read More