We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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’s Pharmacovigilance Risk Assessment Committee scheduled its first-ever public hearing for Sept. 26 in London, and is asking citizens to share their experiences with valproate, a treatment for epilepsy, bipolar disorder and migraines. Read More
A recent survey revealed that drugmakers are facing some challenges in using the European Medicines Agency’s PRIME program for priority medicines, which recently marked its one-year anniversary. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended 11 products for new marketing authorizations, including five orphan drugs. 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
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