FDA Releases Draft Guidance on Minimizing Medication Errors Related to Product Design

The Food and Drug Administration released a draft guidance to help drug sponsors minimize medication errors related to product design, according to a notice published Dec. 13 in the Federal Register (77 Fed. Reg. 74,196).

The draft guidance, Safety Considerations for Product Design to Minimize Medication Errors, is intended to help sponsors of investigational new drug applications, new drug applications, biologics license applications, abbreviated new drug applications, and nonprescription drugs marketed without an approved application, the agency said.

FDA said the draft guidance contains a set of principles for developing drug products using a systems approach. ...