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The FDA has upgraded its rating on Fresenius’ APP Pharmaceuticals New York plant, clearing the facility, which had been troubled by pest problems, to produce new drugs for Fresenius’ Kabi arm. Read More
Drugmakers should notify the European Medicines Agency within 10 days of receiving an initial opinion on a pediatric investigation plan if they plan to request another review. Read More
The FDA warned Thursday that counterfeit versions of Eli Lilly’s popular erectile dysfunction drug Cialis were found in mail to a U.S. customer — marking the first major counterfeit incident of 2015. Read More
Authorities in the UK are urging physicians not to prescribe valproate drugs to pregnant women and to inform women who truly need the drug of potential risks to their unborn children. Read More
The European Medicines Agency has published a 100-page technical guide aimed at helping drugmakers comply with a new global standard on the reporting of individual case safety reports. Read More