Considerations for tissue-engineered and regenerative medicine product development prior to clinical trials in the United States

Tissue Engineering - Part B: Reviews

Volumn 16, Issue 1, 2010, Pages 41-54

  Lee, Mark H ^a   Arcidiacono, Judith A ^a   Bilek, Anastacia M ^b   Wille, Jeremiah J ^b   Hamill, Caitilin A ^b   Wonnacott, Keith M ^a   Wells, Martha A ^a   Oh, Steven S ^a  

^a CENTER FOR BIOLOGICS EVALUATION AND RESEARCH   (United States)

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CHARACTERIZATION TECHNIQUES; CLINICAL TRIAL; COMMERCIAL PRODUCTS; DEVELOPMENT PROCESS; FOOD AND DRUG ADMINISTRATION; PRODUCT DEVELOPERS; REGENERATIVE MEDICINE;

PRODUCT DEVELOPMENT;

DRUG PRODUCTS;

BIOLOGICAL PRODUCT;

CLINICAL RESEARCH; DEVICE; FEEDBACK SYSTEM; FOOD AND DRUG ADMINISTRATION; HUMAN; NONHUMAN; PRIORITY JOURNAL; PRODUCT DEVELOPMENT; REGENERATIVE MEDICINE; REVIEW; SAFETY; TISSUE; TISSUE ENGINEERING; UNITED STATES; XENOGRAFT;

CLINICAL TRIALS AS TOPIC; DRUG AND NARCOTIC CONTROL; HUMANS; REGENERATIVE MEDICINE; TISSUE ENGINEERING; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 76749103420     PISSN: 19373368     EISSN: None     Source Type: Journal    
DOI: 10.1089/ten.teb.2009.0449     Document Type: Review

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