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Ranitidine can generate N-nitrosodimethylamine (NDMA) when stored at higher temperatures, a research laboratory has found, raising new safety concerns. Read More
So far major pharmacies are silent on a new federal court order for CVS Health, Rite-Aid, Walgreens, Walmart and other pharmacy defendants in the nationwide opioid multidistrict litigation (MDL) to submit 14 years of opioid dispensing data. Read More
The drug “represents an important new option for the acute treatment of migraine,” according to Billy Dunn, acting director of CDER’s Office of Neuroscience. Read More
Following two previous years of significant increases the agency is no longer “running on fumes” according to the Alliance for a Stronger FDA. Read More
The FDA is taking issue with a new study that says the agency can’t tell if its risk evaluation and mitigation strategy (REMS) program for extended-release and long-acting opioids is effective. Read More