Lexology February 6, 2023
OVERVIEW
As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global economies. The agency’s reach continues to expand with the proliferation of outsourced and offshore manufacturing, clinical trials and global supply chains. The past year was notable for FDA’s continued efforts to align and scale its regulatory processes to keep pace with growing innovation in drug and device development and food production, and the rise and market dominance of in vitro diagnostics (IVDs), including laboratory-developed tests (LDTs), in the wake of the COVID-19 pandemic. Congress’s failure to enact the long-awaited and hotly contested Verifying Accurate Leading-edge IVCT...
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