Articles tagged with “uspi”

USPI Highlights: A Guide to FDA Drug Labeling Requirements

Learn to write the Highlights of Prescribing Information (HPI). Updated for 2026 with AI labeling tools, the Prescription Information Modernization Act, and generic drug labeling reforms. Covers FDA requirements, PLR, and best practices.

45 min read

11/23/2025

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

Off-Label Promotion: A Compliance Guide for MSL Teams

Updated 2026 guide to FDA off-label promotion regulations for MSL teams, covering the January 2025 SIUU guidance, September 2025 OPDP enforcement surge, USPI boundaries, and compliance best practices

40 min read

11/22/2025

off-label promotion msl compliance medical affairs fda regulations uspi scientific exchange pharmaceutical compliance