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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
German health officials called for a ban on imports to the European Union from a plant operated by Dr. Reddy’s Laboratories in India, following inspections finding poor quality controls, dirty equipment, and other shortcomings. Read More
The European Medicines Agency invited stakeholders to comment on a planned guidance on nonclinical development of radiopharmaceutical products. Read More
The UK’s National Institute for Health and Care Excellence ruled that Merck’s cancer immunotherapy Keytruda is not cost-effective in metastatic urothelial carcinoma. Read More
The European Medicine Agency’s safety committee is recommending labeling changes for several products to cover newly identified risks of adverse events and side effects. Read More
More than 120 questions and answers were added to the European Medicines Agency’s FAQs on the launch of the new EudraVigilance reporting system, set to go live Nov. 22. Read More
Variations in right-to-try laws passed in multiple states and at the federal level could mean compliance headaches for companies taking part in expanded access. Read More
Managing drug treatments for children may call for communicating with them via Facebook, videos or comics, the European Medicines Agency said in draft guideline on pharmacovigilance practices for pediatric populations. Read More
The European Medicines Agency released a reflection paper to help guide generic drugmakers through the process of setting specifications for in vitro dissolution of immediate-release oral drugs. Read More
The European Medicines Agency conducted 15 percent more inspections for compliance with good clinical practices in 2016 than in 2015, the agency reported. Read More