The long-anticipated rule significantly overhauls the way drugs and biologics are labeled. Designed to improve the communication of risks and benefits, Implementation will be a massive, costly undertaking. To meet the new design and content requirements, most package inserts will be twice as long, requiring manufacturers to change packaging lines and label printing operations for many products. FDA agrees to keep type fonts fairly small, but many new labels will need an additional page, which represents a big expenditure.
Source: Pharma Exec.com
Source: Pharma Exec.com
