GRP safety standards will require more thorough NDA preparation by sponsors -- Wyeth's Derivan.
GRP SAFETY STANDARDS WILL REQUIRE MORE THOROUGH NDA PREPARATION, WYETH-AYERST Assistant VP- Research Albert Derivan, MD, indicated at a Dec. 18 Good Review Practices Integrated Safety Review workshop. "We want to do everything that we can to ensure a speedy review and if we can prepare the documents so that it can be reviewed quickly, we're going to do that," he said. The meeting discussed an FDA guidance on integrated safety reviews ("The Pink Sheet" Dec. 9, p. 6).
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