Regulation of immunotherapeutic products for cancer and FDA's role in product development and clinical evaluation

Journal for ImmunoTherapy of Cancer

Volumn 1, Issue , 2013, Pages

  Vatsan, Ramjay S ^a   Bross, Peter F ^a   Liu, Ke ^a   Theoret, Marc ^b   De Claro, Angelo R ^b   Lu, Jinhua ^a   Helms, Whitney ^b   Niland, Brian ^a   Husain, Syed R ^a   Puri, Raj K ^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

IMMUNOMODULATING AGENT;

BIOLOGICAL ACTIVITY; BIOTECHNOLOGY; BODY WEIGHT; CANCER IMMUNOTHERAPY; CLINICAL EVALUATION; DRUG EFFICACY; DRUG POTENCY; EVIDENCE BASED MEDICINE; FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; HUMAN; IMMUNOPHENOTYPING; MANUFACTURING INDUSTRY; MYCOPLASMA; NEOPLASM; PRIORITY JOURNAL; QUALITY CONTROL; REVIEW; TRANSMISSION ELECTRON MICROSCOPY; TUMOR REGRESSION; VACCINATION;

EID: 84991035719     PISSN: None     EISSN: 20511426     Source Type: Journal    
DOI: 10.1186/2051-1426-1-5     Document Type: Review

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