As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. ...more
The U.S. Food and Drug Administration (FDA) has issued two new draft guidance documents on pediatric drug development and exclusivity, most notably clarifying that, under a new proposed policy that would come into play upon...more
New guidance intends to limit product sponsors’ exclusions from the requirement to study pharmaceuticals in pediatric patients. On December 20, 2017, the US Food and Drug Administration (FDA or Agency) issued draft...more