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Numerous federal agencies have strategies to address illicit opioid use but almost all lack concrete goals and outcome-oriented performance measures, the Government Accountability Office said in a new report. Read More
The U.S. Court of Appeals for the Fourth Circuit struck down Maryland’s generic drug pricing law Friday, ruling that the law is unconstitutional because it regulates trade beyond the state’s borders. Read More
The FDA finalized guidance on its special protocol assessment (SPA) program that offers sponsors an advanced declaration from the agency that their trial designs, clinical endpoints, and statistical analyses are acceptable. Read More
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