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FDA Proposed Rule: Always Expedited Reports13

  • Specific SADRs, regardless of expectedness/seriousness,

to be reported on expedited basis due to medical gravity:

Congenital anomalies Ventricular fibrillation Malignant hypertension Agranulocytosis Toxic epidermal necrolysis Acute liver failure Acute renal failure Pulmonary hypertension

Acute respiratory failure Torsades de pointe Seizure Aplastic anemia Liver necrosis Anaphylaxis Sclerosing syndromes Pulmonary fibrosis

13www.fda.gov/OHRMS/DOCKETS/98fr/03-5204.pdf

©sagcs 2007

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