Biotech Values

[DewDiligence]

Another FDA document on QTc-prolongation:

Draft Consensus Guideline: Safety Pharmacology Studies for Assessing the Potential for Delayed Ventricular Repolarization
(QT Interval Prolongation) by Human Pharmaceuticals

http://www.fda.gov/cder/guidance/4970dft.htm

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Based on an FDA communication issued today (below), the above QTc guidance from 2002 has not been superseded.

Source: Comprehensive List of Guidance Documents (updated) March 8, 2004: http://www.fda.gov/cder/guidance/guidlist.pdf