Articles tagged with “drug-labeling”

Safety Signal to Label Update: How Modern PV Systems Work

Learn the end-to-end pharmacovigilance process for translating safety signals into drug label updates. This guide explains CCDS and how Vault Signal accelerates

30 min read

11/24/2025

pharmacovigilance drug labeling veeva vault signal safety signal management regulatory affairs ccds drug safety

Writing a Target Product Profile (TPP) for Drug Development

A guide to the Target Product Profile (TPP), a strategic document for drug development. Learn its components, purpose, and how to align it with the final drug l

40 min read

11/24/2025

target product profile tpp drug development drug labeling regulatory affairs fda guidance clinical development regulatory strategy

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