Topic: ANDA

FDA’s Proposed Rule on Generic Drug Labeling Could Sow Confusion and Chaos (and Lawsuits)

The FDA wants to give generic drug makers the same labeling authority as their branded peers. Attorneys Erin Bosman, James Huston, and Julie Park of Morrison & Foerster explain: [T]he U.S. Food and Drug Administration (FDA) published a long-awaited proposed rule … in an effort to ‘create parity’ between brand-name and generic manufacturers for their… Read more »