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Boxed Warnings, Drug Watch Are Policy Goals Of Drug Safety Oversight Board

Executive Summary

FDA's Drug Safety Oversight Board should start shifting its focus toward broader policy questions - like standards for boxed warnings - in addition to addressing emerging safety issues for specific products, DSOB Executive Director Susan Cummins suggested

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FDA expects to release its revised Drug Watch guidance "very soon," according to CDER Director Steven Galson. "We're very close to completing the guidance that responds to the initial draft we put out and comes up with decisions on each of those questions that were raised," Galson says Sept. 22. The original plans for a website for posting emerging risk information drew intense criticism, prompting FDA to redraft the guidance (1"The Pink Sheet" Feb. 21, 2006, p. 5)...

Re-release of Drug Watch guidance

FDA expects to release its revised Drug Watch guidance "very soon," according to CDER Director Steven Galson. "We're very close to completing the guidance that responds to the initial draft we put out and comes up with decisions on each of those questions that were raised," Galson says Sept. 22. The original plans for a website for posting emerging risk information drew intense criticism, prompting FDA to redraft the guidance (1"The Pink Sheet" Feb. 21, 2006, p. 5)...

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