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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
Tasked with thinking beyond the agency’s current policy proposals, the FDA created a new working group of senior staff members to develop ways to boost generic competition, according to Commissioner Scott Gottlieb. Read More
The European Medicines Agency revised its guideline on first-in-human clinical trials, highlighting the sponsor’s responsibility for mitigating risks to volunteers.in the study design. Read More
The European Medicines Agency adopted five product-specific guidances, effective Jan. 1, 2018, outlining requirements for establishing bioequivalence, including clinical study design. Read More
A joint FDA advisory committee voted against recommending approval of Intellipharmaceutics’ extended-release opioid painkiller Rexista, as well as against the claim that it deters abuse. Read More
The FDA does not intend to object to an institutional review board waiving informed consent requirements for certain clinical investigations considered to be “minimal risk,” according to a new agency guidance effective immediately. Read More