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- FDA issues warning letters to drug makers and a lab over CGMP and GLP violationsFDA sent warning letters to several drug manufacturers for not meeting current good manufacturing practice (CGMP) requirements. The letters point to issues such as ensuring final product sterility…
- FDA launches Rare Disease Framework Initiative to overhaul review processThe FDA announced a new Rare Disease Framework Initiative aimed at redesigning how therapies for rare conditions are regulated. The initiative will move away from a one-size-fits-all model, instea…