Actions for Premarket approval application filing review

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Premarket approval application filing review

Additional Titles
At head of title: Guidance for industry and FDA staff
Published
[Rockville, Md.] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, [2003]
Physical Description
12 pages, 12 pages : digital, PDF file
Additional Creators
Center for Devices and Radiological Health (U.S.) and Center for Biologics Evaluation and Research (U.S.)
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Restrictions on Access
Free-to-read Unrestricted online access
Report Numbers
HE 20.4802:P 91/4
Subject(s)
Note
Title from PDF title page (viewed on May 26, 2009).
"Document issued on: May 1, 2003".
Technical Details
Mode of access: Internet at the FDA CBER web site. Address as of 5/26/09: http://www.fda.gov/cdrh/ode/guidance/297.pdf ; current access is available via PURL.
Action Note
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