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There is no compelling reason, according to the petition, why the FDA should not approve generic competitors’ ANDAs as long as they meet accepted quality standards. Read More
The FDA cited multiple problems with labeling claims at a Phoenix manufacturer that specializes in colostrum, the milk produced by maternal mammals immediately after giving birth. Read More
The European Medicines Agency conducted 15 percent more inspections for compliance with good clinical practices in 2016 than in 2015, the agency reported. Read More
The FDA approved Adamas Pharmaceuticals’ Gocovri (amantadine) for the treatment of dyskinesia in Parkinson’s disease patients receiving levodopa therapy, making it the first drug to be approved for that condition. 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