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The FDA issued a warning letter to an over-the-counter drug manufacturer in Hangzhou, China for serious GMP violations including inadequate testing for drug products prior to release. Read More
A New York federal judge has dismissed a whistleblower suit alleging that Novartis paid physicians kickbacks to prescribe its multiple-sclerosis drug Gilenya. Read More
The FDA cited Anchen Pharmaceuticals for four violations at its manufacturing facility in Irvine, California, including particulate contamination. Read More
The FDA issued a warning letter to DermaPharm for serious GMP violations including inadequate testing of raw materials and finished products. Read More
The FDA has removed an Indian supplier of hydroxychloroquine and chloroquine APIs from an import alert to free up imports of the potential COVID-19 treatments from two of its plants. Read More
Sponsors who fail to meet certain Risk Evaluation and Mitigation Strategy (REMS) requirements won’t face FDA action during the COVID-19 outbreak, the agency announced. Read More