Business · 31/05/2018Updated: 10/17/2026 · 1 min read
FDA Announces Availability of Q12 Guidance on Pharmaceutical Product Lifecycle Management
Summary
The FDA has released a draft guidance document, Q12, developed by the International Council for Harmonisation, outlining technical and regulatory considerations for managing post-approval changes in pharmaceutical products.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →