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The FDA on Feb. 25 released new information that shows the scope of its efforts to investigate the efficacy and bioequivalence of generic drugs, publishing summaries of ongoing research. Read More
FDA efforts to standardize capsule and tablet sizes for generic drugs are unnecessary and will strain relationships with suppliers, generic drugmakers say. Read More
Drugmakers in the EU are pushing back against a proposal moving through the EU Parliament that would grant clinical trial participants the right to demand that their trial data — including data shared between regulators and other entities — be deleted. Read More
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