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. Source:…
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…
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…
A whistleblower lawsuit accuses Mallinckrodt of systemically concealing concerns about the composition of its drug Acthar, indicated for treatment of infantile spasms. Source: Drug Industry Daily
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. Source: Drug Industry Daily
The FDA cited API manufacturer CIL Isotope Separations after an inspection of its Xenia, Ohio facility revealed quality control issues, investigational deficiencies and other violations. Source: Drug Industry Daily
An Ohio judge ordered the Drug Enforcement Administration to turn over more data in multidistrict litigation against opioid manufacturers and distributors. Source: Drug Industry Daily
The FDA hit Pfizer subsidiary Pharmacia & Upjohn with a Form 483 for inadequate employee training, poor equipment maintenance practices and inadequate sample inspection procedures. Source: Drug Industry Daily
The EU reassigned oversight of more than 370 centrally authorized drugs from UK agencies to other EU member states in anticipation of Brexit. Source: Drug Industry Daily
A group of hemophilia patients and activists petitioned the FDA to hold a public hearing on court-ordered drug restrictions after an intellectual property suit filed by Shire requested restricted access…