Serious Adverse Drug Experience definition

Serious Adverse Drug Experience means any Adverse Drug Experience, including those subject to expedited reporting as defined in the regulations cited below, that is fatal or life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect, or is of comparable medical significance or any other event which would constitute a “serious” Adverse Drug Experience pursuant to the terms of 21 C.F.R. 314.80 or 312.32.

Serious Adverse Drug Experience means any of an “adverse drug experience,” a “life-threatening adverse drug experience,” a “serious adverse drug experience,” or an “unexpected adverse drug experience,” as those terms are defined at either 21 C.F.R. § 312.32 or 21 C.F.R. § 314.80 or relevant foreign regulation within the Territory.

Serious Adverse Drug Experience means any adverse drug experience occurring at any dose that results in any of the following outcomes: death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a Serious Adverse Drug Experience when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

Examples of Serious Adverse Drug Experience in a sentence

• Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a Serious Adverse Drug Experience when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

• Upon receipt of any such information concerning any Serious Adverse Drug Experience or unexpected adverse drug experience or information that would require an IND safety report as described in 21 CFR 312.32 by either PRONOVA or RELIANT, the Parties shall promptly consult each other and use commercially reasonable efforts to arrive at a mutually acceptable procedure for taking such possible actions as appropriate or required under the circumstances.

• Each party shall consult with, and reasonably consider input of the other party in making the determination whether any complaint, Adverse Drug Experience Report or Serious Adverse Drug Experience Report must be reported to the FDA or any other Governmental or Regulatory Authority or any other Person.

• PFIZER shall provide all reasonable cooperation with any investigation of any such spontaneous Adverse Drug Experience Report or Serious Adverse Drug Experience Report conducted by XXXXXX-XXXXXXX.

• All other follow-up investigations concerning Adverse Drug Experience Reports and Serious Adverse Drug Experience Reports shall be conducted by XXXXXX-XXXXXXX.

More Definitions of Serious Adverse Drug Experience

Serious Adverse Drug Experience shall have the meaning assigned to such term in Section 6.2.1 hereof.

Serious Adverse Drug Experience. Section 13.3(b)

Serious Adverse Drug Experience means any adverse drug experience occuring at any dose that results in any of the following outcomes: death, a life-threatening adverse drug experience, inpatient hospitalization or prolongment of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse drug experience when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. An unexpected adverse drug experience is one that is not listed in the current labeling for a drug product. This includes events that may be symptomatically and pathophysiologically related to an event listed in the labeling, but differ from the event because of greater severity or specificity.

Serious Adverse Drug Experience. Any adverse drug experience occurring at any dose that results in any of the following outcomes: death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital 9 The definition of inordinate amounts in this MOU is separate and distinct from and should not be used in relation to the term inordinate amounts as it is used in section 503A(b)(1)(D) of the FD&C Act (pertaining to compounding a drug product that is essentially a copy of a commercially available drug product). The interpretation of this term in each instance necessarily is based on the particular context of the distinct provisions within 503A in which the term appears. anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse drug experience when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse (21 CFR 310.305(b)).

Serious Adverse Drug Experience means any adverse drug experience occurring at any dose that results in any of the following outcomes: death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or

Serious Adverse Drug Experience. (SAE) means “Any adverse drug experience occurring at any dose that results in any of the following outcomes: death, a life- threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life- threatening, or require hospitalization may be considered a serious adverse drug experience when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.”

Serious Adverse Drug Experience. Section 13.2 “SPC”—Section 9.3. [* * *]