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Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links A-Z Index Home Food Drugs Medical Devices Cosmetics Radiation-Emitting Products Tobacco Products - FDA Home > Medical Devices > Databases CFR - Code of Federal Regulations Title 21 510(k) | Listing | Adverse Events | Recalls | PMA | Classificatio n | Standards CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA
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New Search Help | More About 21CFR [Code of Federal Regulations] [Title 21, Volume 5] [Revised as of April 1, 2010] [CITE: 21CFR312.32] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER D--DRUGS FOR HUMAN USE PART 312 -- INVESTIGATIONAL NEW DRUG APPLICATION Subpart B--Investigational New Drug Application (IND) Sec. 312.32 IND safety reports. (a) Definitions. The following definitions of terms apply to this section: Associated with the use of the drug. There is a reasonable possibility that the experience may have been caused by the drug. Disability. A substantial disruption of a person's ability to conduct normal life functions. Life-threatening adverse drug experience. Any adverse drug experience that places the patient or subject, in the view of the investigator, at immediate risk of death from the reaction as it occurred, i.e. , it does not include a reaction that, had it occurred in a more severe form, might have caused death.
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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 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
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