Guidance

Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry

GMP Guide for Drug Products GUI-001 Canada

Definitions of Suspect Product & Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance

FDA Unique Device Identification: Direct Marking of Devices

FDA Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier

CDER Issues Planned Guidance Agenda for CY2018

EMA Guideline on Manufacture of the Finished Dosage Form

Classification of Products as Drugs and Devices & Additional Product Classification Issues: Guidance for Industry and FDA Staff

Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy.

FDA Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification

EMA Implementation Strategy of ICH Q3D Guideline

EU ICH Guideline Q3C R6 on Impurities Guideline for Residual Solvents

Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products

Agreement on Mutual Recognition Between EU Community and US FDA