RAPS

Human Factors Studies for Generic Combo Products: FDA Offers Draft Guidance

The US Food and Drug Administration (FDA) on Friday continued its flurry of draft guidance for generic drug companies (releasing its third in the last two days), this one for potential applicants ...
RAPS

Human Factors Submissions and Threshold Analyses: FDA Drafts Guidance

The US Food and Drug Administration (FDA) on Friday drafted guidance to help sponsors with the content and submission procedures for use-related risk analyses, human factors (HF) validation study ...