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The FDA has failed to properly address safety issues relating to an over-the-counter teething medication and should act within 30 days to remedy the situation, a lawsuit by Public Citizen said. Read More
The European Medicine Agency’s safety committee is recommending labeling changes for several products to cover newly identified risks of adverse events and side effects. Read More
More than 120 questions and answers were added to the European Medicines Agency’s FAQs on the launch of the new EudraVigilance reporting system, set to go live Nov. 22. Read More
Missouri’s Supreme Court upheld a $38 million verdict against Abbott Laboratories over claims its epilepsy drug Depakote caused birth defects. Read More
The FDA has largely succeeded in expediting the review of drugs with larger health gains, but postmarket trials by companies have fallen behind in confirming some of those benefits, with many not using the gold standard of randomized controlled trials, according to two independent studies. Read More
An FDA advisory committee voted 13-to-1 in favor of adding a warning about the risk of gadolinium retention to prescribing information for gadolinium-based contrast agents used in MRI scans. Read More
The FDA directed a Canadian opioid manufacturer to send information to doctors correcting the complete absence of warnings of serious risks associated with the drug in professional promotional materials distributed earlier. Read More
More than 120 questions and answers were added to the European Medicines Agency’s FAQs on the launch of the new EudraVigilance reporting system, set to go live Nov. 22. Read More
The FDA directed a Canadian opioid manufacturer to send information to doctors correcting the complete absence of warnings of serious risks associated with the drug in professional promotional materials distributed earlier. Read More
Consumers find short lists of drug risks in broadcast advertising easier to recall, according to a new study by researchers at the FDA and RTI International’s Center for Communication Science. Read More