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’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
A Chinese heparin contract testing lab has been warned by the FDA for significant cGMP violations, recalling unresolved questions and concerns from the Chinese heparin scandal a decade ago. Read More
The European Medicines Agency is putting off plans for GMP inspections in the U.S. when possible, an EMA spokesperson confirmed, in anticipation of the November launch of a mutual agreement between the EU and U.S. Read More
The FDA found numerous faults during inspections this year of the PharmaTech facility in Davie, Fla. — resulting in the agency issuing a Form 483 that described shortcomings in product-testing, packaging, labeling, and other procedures at the facility. Read More