Amendment ID: S1899-7-R1

Redraft Amendment 7

Defining Serious Adverse Drug Event

Messrs. Montigny and Tarr move to amend the amendment in section 7, at lines 120 to 124 by striking out after the word “regulation” in line 120 the words “;provided,  however, that serious adverse medical occurrences directly associated with the use of a drug in humans that may not immediately result in death, be life threatening or require hospitalization may be considered serious when, based upon appropriate medical judgment, they develop into or result in 1 of  the outcomes listed in this definition.”