
The Beat Goes On – More On the Proposed Rule
This edition of the Proposed Rule saga covers a few more interesting issues. The rule-which was 11 years in the making (longer than the final Hatch-Waxman rule on the patent and exclusivity provisions of the Act, which was10 years in the making) really tightens up some of the long-established practices of the Agency and explains why the FDA is taking the actions that it is. Makes for good reading, but make sure you have your toothpicks ready to prop open your eyes. We are just through page 120 of the 300+ pages.