180-day exclusivity rule on hold
Executive Summary
"With the recent court decisions, not only already acted upon but pending, as well as the McCain/Schumer bill, things are very, very open to changing," OGD's Davis said. FDA's "180-day final rule for all intents and purposes right now is on hold." McCain/Schumer would allow rolling exclusivity (1"The Pink Sheet" May 7, p. 8)
"With the recent court decisions, not only already acted upon but pending, as well as the McCain/Schumer bill, things are very, very open to changing," OGD's Davis said. FDA's "180-day final rule for all intents and purposes right now is on hold." McCain/Schumer would allow rolling exclusivity (1 (Also see "McCain/Schumer Generic Bill Would End 30-Month Stay Of Approval" - Pink Sheet, 7 May, 2001.)). |