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The reduction in the number of notice of violation letters seen in the Bush and three first years of the Obama administrations may result in using FDA scarce resources to target the most significant violations of the regulation, but also that a significant number of violations of federal regulations are not disclosed, prosecuted, and corrected.
This shift in enforcement strategy may explain why the number of warning letters –used for significant regulatory violations- remained relatively unchanged during the second Clinton and the two Bush administrations; while the number of notice of violation letters used for less serious violations- declined significantly during the same period.
The 2002 change in procedures that directed the FDA to forward all drafts of regulatory letters to the FDA's Office of Chief Counsel for review and approval, [ 5] resulted in a substantial decline in the number of notice of violation letters [ 5, 6, 10].
And the number of notices is far below the 25,000 that were sent out in the peak of the recession in 2010.
Finally, we qualitatively assessed dumpster risk categories (Refuse Collectors section) and summarized the number of notices given to each.
However, the average annual number of notices of violation released between the second Clinton administration and the Bush administrations decreased by 81.7% from 114.3 to 20.9 letters, respectively.
Availability of limited funds for FDA enforcement efforts is another factor that may explain the reduction in the number of notices of violation letters by the Bush administrations and the first three years of the Obama administration [ 8].
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