Call for Comments: FDA Industry Guidance To Prevent Medication Errors

FDA has released a draft guidance for industry, “Safety Considerations for Product Design to Minimize Medication Errors.” The draft guidance provides sponsors of investigational new drug applications, new drug applications, biologics licensing applications, abbreviated new drug applications and nonprescription drugs marketed without an approved application (e.g., monograph) with a set of principles for developing drug products using a systems approach to minimize medication errors relating to product design. The draft guidance also includes recommendations intended to improve the drug product and container closure design at the earliest stages of product development for all prescription and nonprescription drug products. To submit comments: To ensure that the FDA considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 11, 2013. Submit electronic comments on the draft guidance to http://www.regulations.gov. For details, see Federal Register Notice.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guida...