FDA Approves First State Drug Importation Program Under 20-Year-Old Statute, But High Hurdles Remain
FDA Law Blog
JANUARY 9, 2024
After its enactment in 2003, successive administrations thwarted its implementation by declining to certify to Congress that importation will pose no additional risk to public health and safety and will result in a significant reduction in cost to American consumers, as the statute requires. See 21 C.F.R. 251.5; § 251.6(c).
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