FDA Guidance for Industry: Safety Considerations for Product Design to Minimize Medication Errors
Title:
FDA Guidance for Industry: Safety Considerations for Product Design to Minimize Medication Errors
Origin/Publisher:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM331810.pdf
Content:
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.