Business · 09/06/2010Updated: 10/17/2026 · 1 min read

FDA Announces Proposed Collection of Information for Biologics License Applications and Labeling

The Food and Drug Administration (FDA) has submitted a proposed collection of information to the Office of Management and Budget (OMB) for review and clearance, focusing on general licensing provisions for biologics license applications, labeling, and postmarketing studies status reports.