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Sponsors should gather supportive data from two definitive clinical trials to establish efficacy for drugs proposed to treat chronic fatigue syndrome/myalgic encephalomyelitis, the FDA says. Read More
The FDA is scaling back the number of routine quality inspections it plans to conduct in the U.S. each year by 40 percent in favor of conducting more inspections overseas. Read More
Indian generics makers Sun Pharma and Ranbaxy are both facing individual Class II U.S. recalls related to product mixups. Both recalls were included in the FDA’s March 5 enforcement report. Read More
The FDA is voicing new safety concerns with the next-generation heart drugs known as PCSK9 inhibitors, asking drugmakers to flag any neurocognitive adverse events associated with the class of drugs. Read More
The European Medicines Agency (EMA) is calling on EU makers of seasonal influenza vaccines to develop enhanced safety signal monitoring systems that identify increases in allergic reactions, moving away from systems that simply check for specific batch deviations. Read More
Drug safety assessors in the EU are urging tougher restrictions on drugs containing domperidone used in anti-vomiting treatments such as Janssen’s Motilium, due to potential heart risks. Read More
Pfizer is recalling three lots of drug products after a packaging mix-up led to a capsule of the wrong drug product in a bottle of an antidepressant. Read More
The FDA will create a pharma-only enforcement unit that promises more consistent inspections and enforcement decisions with fewer bureaucratic hurdles for investigators to issue warning letters. Read More
The FDA and European Medicines Agency (EMA) have launched a new information-sharing initiative they hope will coordinate and speed international responses to drug safety problems. Read More