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Guidance for industry : providing regulatory submissions in electronic format, general considerations.

Available copies

  • 2 of 2 copies available at Evergreen Indiana.

Current holds

0 current holds with 2 total copies.

Location Call Number / Copy Notes Barcode Shelving Location Status Due Date
Indiana State Library - Indianapolis HE 20.4802:R 26/5 (Text) 991886-1001 Online document Available -
Indiana State Library - Indianapolis HE 20.4802:R 26/5/DRAFT (Text) 991886-2001 Online document Available -

Record details

  • Physical Description: 20 pages : digital, PDF file
  • Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : [2003]

Content descriptions

General Note: Title from PDF title page (viewed on May 26, 2009).
"Draft guidance".
"October 2003".
"Electronic submissions".
"Revision 1".
System Details Note: Mode of access: Internet at the FDA CBER web site. Address as of 5/26/09: http://www.fda.gov/cber/gdlns/elecgenrev1.pdf ; current access is available via PURL.
Subject: Electronic filing systems > Government policy > United States.

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