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The future of the pharmaceutical industry will involve increased use of master protocols, trial platforms and clinical-trial networks, said CDER director Janet Woodcock this week at a National Academies of Sciences, Engineering and Medicine workshop on real-world evidence in Washington, D.C. Read More
A coalition of state attorneys general suing opioid manufacturers has expanded the investigation of marketing and sales practices to include several branded painkiller manufacturers and drug distributors. Read More
New guidance from the UK’s National Institute of Health and Care Excellence links the cost-effectiveness of different bisphosphonate medications for osteoporosis with a patient’s 10-year risk of bone fractures. Read More
The European Medicines Agency published an internal guide on the use of multinational assessment teams for pre-authorization reviews and post-authorization extensions for new medicines. Read More