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Searching Content indexed under Life Sciences, Biotechnology & Nanotechnology by William Gould ordered by Published Date Descending.
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Government's Response to Pharmaceutical Companies' "Catch-22" Raises Additional Questions
"[W]hen a manufacturer speaks about an on-label use of its drug in a medical facility where physicians prescribe the drug off-label, the manufacturer is caught in a Catch-22: changing the drug’s labeling to add directions for the off-label use violates the Act’s criminal ‘new drug’ rule, but based on the government’s view of the FDA’s ‘intended use’ regulations, not changing the labeling to add those directions violates the Act’s criminal ‘misbranding’ rule.
United States
 
9 Feb 2012
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