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US FDA Gives Directions On Navigating Generic 180-Day Exclusivity Maze

 
• By Brenda Sandburg

Draft guidance sums up agency’s policies for determining exclusivity, clarifies when the clock starts for failure to market.

FDA entrance sign 2016

For more than a decade, ANDA sponsors have struggled with FDA over the complex rules for obtaining 180-day marketing exclusivity. The agency recently issued a guidance that answers 45 of the most commonly asked questions about the policy, which may help firms get through the labyrinth.

The draft guidance, 180-Day Exclusivity: Questions and Answers, sums up the positions FDA has taken in litigation, responses...

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