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When Mallinckrodt acquired Questcor in 2014, the ingredients/recipe was transferred in a file that could not be accessed, the complaint states. Read More
Of the 944 unique sites inspected, the program identified 458 “common interest” sites and found they were primarily located in India and China. Read More
A whistleblower lawsuit accuses Mallinckrodt of systemically concealing concerns about the composition of its drug Acthar, indicated for treatment of infantile spasms. Read More
A European Medicines Agency report states that 944 API manufacturers were inspected in the first six years of the International Active Pharmaceutical Ingredient Inspection Program. Read More
An Ohio judge ordered the Drug Enforcement Administration to turn over more data in multidistrict litigation against opioid manufacturers and distributors. Read More
The FDA’s processes are threatened by a new legal approach that would deny access to approved drugs based on non-medical issues, the petition claimed. Read More
UK officials will hand over their work in the EU’s Pharmacovigilance Risk Assessment Committee, the Committee for Medicinal Products for Human Use and the Committee for Advanced Therapies. Read More
The EU reassigned oversight of more than 370 centrally authorized drugs from UK agencies to other EU member states in anticipation of Brexit. Read More