FDA Advises Medication Error Risk Assessment Early In Development

 
• By Elizabeth Crawford

FDA’s draft guidance on safety considerations for product and container design to minimize medication errors calls for assessments in “real world” settings early in the development process. Relying solely on clinical trials is inadequate for a number of factors the agency and sponsors need to know about a new drug product, the draft says.

Manufacturers should assess consumers’ use of products in “real world” settings early in the development process to minimize medication errors, FDA suggests in a draft guidance on safety considerations for product and container design.

Assessments early in development can help identify and reduce potential medication errors and avoid costly post-approval redesigns, the agency says...

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