North America

Hands holding a medicine bottle.

FDA Issues Final Guidance on Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors

FDA has issued the final guidance titled “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.” The recommendations for prescription drug and...

Gloved hands holding up vials over a laptop keyboard.

Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production - Level 2 revision

Guidance for Industry May 2022 Today, FDA is announcing revisions to the 2006 guidance “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.” Specifically, this...