manufacturing facility / autologous fibroblast product / protein-free media / autologous cellular product / culture media qualification / chemical peels / inadequate media / autologous product / manufacturing process steps / manufacturing processes / stability protocol / manufacturing process / final product / cellular product / study site / identical protocols / manufacturing / manufacturing site / clinical site / /
MedicalCondition
Sterility / /
MedicalTreatment
surgery / chemical peels / /
Organization
Offices Signatory Authority / Cellular / Tissue / and Gene Therapies Advisory Committee / office of Compliance / FDA CR / US Food and Drug Administration / FDA / Advisory Committee / /
Person
Terrig Thomas / Craig Zinderman / Charles Durfor / Bruce Schneider / Cell Viability Collagen / Randa Melhem / Agnes Lim / Donald Fink / Jane Liedtka / Janet White / Gene Therapies Mary / Janette Alexander / Aileen Buckler / Patricia Brown / Celia Witten / Lynn Drake / Keith Wonnacott / Therapies Mary Malarkey / Lisa Stockbridge / Lot Release / /
Position
Physician / same evaluator / prescribing physician / Director / Director / Office / evaluator / Chair of the Review Committee / /
Product
Therapy™ (IT) / Exton Pennsylvania / New Drug / azficel-T. A Cellular / R-006 / /
Summary Basis for Regulatory Action Template v 2