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Title Guidance for industry [electronic resource] : MedWatch form FDA 3550A, mandatory reporting of adverse reactions related to human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Imprint Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2005]

Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4802:M 46    ---  Available
Description i, 8 p. : digital, PDF file
System Details Mode of access via the FDA CBER web site.
Note Title from PDF title page (viewed on May 19, 2009).
"November 2005".
Subject Tissue engineering -- United States -- Side effects -- Reporting.
Human cell culture -- Government policy -- United States.
Added Author Center for Biologics Evaluation and Research (U.S.)
Added Title MedWatch form FDA 3550A
Mandatory reporting of adverse reactions related to human cells, tissues, and cellular and tissue-based products (HCT/Ps)
Gpo Item No. 0499-T-02 (online)
Sudoc No. HE 20.4802:M 46

 
    
Available items only