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Congress is looking into making statutory changes to the way FDA governs off-label use of medical products and other pre- and postmarket communications between medical manufacturers, physicians and patients. Read More
The FDA issued a revised version of its ICH-developed guidance on completing the clinical overview section of the Common Technical Document, including more details on risk-benefit submissions. 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
The European Medicines Agency adopted five product-specific guidances, effective Jan. 1, 2018, outlining requirements for establishing bioequivalence, including clinical study design. Read More
The European Medicines Agency is provisionally restricting the use of the multiple sclerosis medicine Zinbryta (daclizumab) to patients with highly active relapsing disease that has failed to respond to certain other treatment, and to patients with rapidly evolving relapsing disease who cannot be treated with other medicines. Read More
The European Medicines Agency and the European Network for Health Technology Assessment developed a joint platform for parallel consultations on evidence plans for marketing authorizations and health technology assessments to provide sponsors with simultaneous, coordinated advice on development strategies. Read More
Swissmedic is revising its drug approval process to streamline authorizations for certain products. The overhaul will take place in several phases, beginning in early 2018. The first revisions will address pediatric drug dosage recommendations. 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’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