Issue Date: April 12, 2016
Issued by: Center for Drug Evaluation and Research
Topic(s): Safety – Issues, Errors, and Problems
Status: Final
Safety Considerations for Product Design to Minimize Medication Errors Guidance for Industry
The recommendations in this guidance apply broadly to the development of drug and biologic products. Accordingly, this guidance is intended for sponsors of investigational new drug applications (INDs); applicants of new drug applications (NDAs), biologics licensing applications (BLAs), abbreviated new drug applications (ANDAs); and manufacturers of prescription drugs marketed without an approved application or over-the-counter (OTC) monograph drugs. This guidance provides a set of principles for using a systems approach to minimize medication errors relating to product design and container closure design and thus enhance patient safety.
Download the Guidance Document
