FDA Chief to Focus on Generics’ Safety on Visit to India
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The head of the U.S. Food and Drug Administration said she will visit India to talk with generic-drug makers and regulators about quality concerns and plans to expand overseas inspections to address the country’s growing role in producing medicines sold in the U.S.
FDA Commissioner Margaret Hamburg said she will ask the drug firms and Indian regulators to “build new partnerships” during her visit beginning Feb. 10. The goal is to reduce the sanitation and testing issues that have led to recent bans on Indian manufacturing plants. India is the second-biggest drug provider and eighth-largest food exporter to the U.S.