The U.S. Food and Drug Administration (FDA) has issued two new draft guidance documents on pediatric drug development and exclusivity, most notably clarifying that, under a new proposed policy that would come into play upon...more
The U.S. Food and Drug Administration (FDA) recently published the draft guidance “Sameness Evaluations in an ANDA – Active Ingredients,” which aims to assist applicants preparing an abbreviated new drug application (ANDA) by...more