Draft guidance sums up agency’s policies for determining exclusivity, clarifies when the clock starts for failure to market.
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The draft guidance, 180-Day Exclusivity: Questions and Answers, sums up the positions FDA has taken in litigation, responses...
Recent studies show that spaceflight can significantly weaken astronauts’ immune systems, making them more susceptible to infections and health complications during and after missions. Understanding these changes is crucial for ensuring the safety of future long-duration space travelers.
Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
