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
You may also be interested in...
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)...
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)...
Risk Assessment Standards From OMB Are Too Broad, FDA’s Galson Says
FDA is concerned that the White House Office of Management & Budget's definition of "risk assessment" outlined in its Proposed Risk Assessment Bulletin would constrain agency action by requiring too many analyses