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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
The FDA will convene a public meeting of its Pediatric Advisory Committee to discuss the use of opioid cough medicines in treating children, part of the agency’s ongoing efforts to address this issue, FDA Commissioner Scott Gottlieb said Aug. 21. 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 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
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
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
The agency will use marketing materials about a fictional weight loss drugs and migraine medications to see who reads and retains risk information better. Read More
The FDA plans to examine if substantive risk information about a drug can be effectively communicated via character-limited social media platforms like Twitter or if just a link will do. Read More