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.
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
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
New Hampshire has joined the long list of states to take legal action against Purdue Pharma, maker of OxyContin (oxycodone), the company’s extended-release prescription opioid painkiller. Read More