FDA: Use Early Systems Approach to Minimize Design-Related Drug Errors

Generic-drug makers should conduct risk assessments at the early stages of drug development and when changes or additions to an already marketed drug product occur to minimize design-related medication errors and avoid post-approval redesigns, according to a new FDA draft guidance. Relying solely on controlled clinical trials to evaluate user interactions is often inadequate, because the controlled environment of clinical trials does not reflect “real world” use, the agency said.
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