FDA Issues Guidances For Chloroquine-Based Drugs To Spur Generics

FDA finalized two product-specific guidances for hydroxychloroquine sulfate and chloroquine phosphate to spur generic drug development, as states , federal agencies and other stakeholders undertake clinical trials and observational studies to explore whether either therapy could work as a treatment for COVID-19. David Gaugh, senior vice president for sciences and regulatory affairs for the Association for Accessible Medicines, said the guidances could help companies that already have approval but haven’t produced the drugs in years get up to speed on...