Perspective: Communications with the food and drug administration on the development pathway for a cell-based therapy: Why, what, when, and how?

Stem Cells Translational Medicine

Volumn 1, Issue 11, 2012, Pages 825-832

  Feigal, Ellen G ^a   Tsokas, Katherine ^b   Zhang, Jiwen ^c   Cromer, Marc V ^d   Whittlesey, Kevin J ^a   Werner, Michael J ^e,f  

^a California Institute for Regenerative Medicine   (United States)

^b JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

^c GE HEALTHCARE   (United States)

^d Life Technologies   (United States)

^e Alliance for Regenerative Medicine   (United States)

^f LLP   (United States)

Author keywords

Cellular therapy; Clinical translation; Stem cells

Indexed keywords

ADVISORY COMMITTEE; ARTICLE; CELL THERAPY; CLINICAL ASSESSMENT; CLINICAL STUDY; DRUG APPROVAL; DRUG EFFICACY; DRUG PROGRAM; DRUG SAFETY; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; HUMAN; INTERPERSONAL COMMUNICATION; NONHUMAN; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); POLICY; PUBLIC HEALTH; RANDOMIZED CONTROLLED TRIAL (TOPIC); REGENERATIVE MEDICINE; REGULATORY MECHANISM; TELECONFERENCE; CELL TRANSPLANTATION; UNITED STATES;

CELL TRANSPLANTATION; COMMUNICATION; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84873025922     PISSN: 21576564     EISSN: 21576580     Source Type: Journal    
DOI: 10.5966/sctm.2012-0104     Document Type: Article

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