The FDA’s Janet Woodcock, director of the Center for Drug Evaluation and Research, testified before a House subcommittee on the national security risk raised by U.S. reliance on China exports of active pharmaceutical ingredients (API). “We cannot assess the extent of U.S. dependence on China,” Woodcock said. While the agency knows the number and location of facilities manufacturing drugs for the U.S. market, it doesn’t “have information about the volume of API being produced in China or even in the United States, or how much of China’s API output reaches the U.S. market through other countries.”

The FDA said it is taking steps toward requiring electronic submission of certain safety reports into the FDA’s Adverse Event Reporting System for products being evaluated under an investigational new drug application. The planned process for submissions is outlined in a new draft guidance, and the FDA is also making available supporting technical specification documents. The regulator said the changes will allow it to access and review both pre- and postmarket safety information in the same system and with the same data standard. s

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