Articles tagged with “21-cfr-201-57”

USPI Highlights: A Guide to FDA Drug Labeling Requirements

Learn to write the Highlights of Prescribing Information (HPI). This guide covers FDA labeling requirements, the Physician Labeling Rule (PLR), and best practic

40 min read

11/23/2025

drug labeling uspi fda regulations physician labeling rule medical writing 21 cfr 201.57 regulatory affairs