Title from title screen (viewed on May 5, 2009). "Draft guidance." "February 2009."
Bibliography Note
Includes bibliographical references (pages 26-27).
Technical Details
Mode of access: Internet from the CDER web site. Address as of 5/5/09: http://www.fda.gov/cder/guidance/7927dft.pdf; current access available via PURL.
Action Note
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