2004D-0187 - Draft Guidance for Industry on Premarketing Risk Assessment; Development and Use of Risk Minimization Action Plans; and Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment; Availability
FDA Comment Number : EC1
Submitter : Ms. Melodi McNeil Date & Time: 07/07/2004 05:07:29
Organization : FDA/OPaSS
Category : Federal Government
Issue Areas/Comments
GENERAL
GENERAL
This comment pertains to the Draft Guidance for Industry on Premarketing Risk Assessment. At line 617 (in section VI, "DATA ANALYSIS AND PRESENTATION," Part A, "Describing Adverse Events to Identify Safety Signals," subsection 1, "Accuracy of Coding," second bullet, second paragraph), the word "liability" should be replaced by the word, "lability," so that the sentence reads, "...verbatim term suicidal ideation as the more benign term emotional lability."