Investigational new drugs submitted to the Food and Drug Administration that are placed on clinical hold: The experience of the Office of Cellular, Tissue and Gene Therapy

Cytotherapy

Volumn 10, Issue 3, 2008, Pages 312-316

  Wonnacott, Keith ^a   Lavoie, D ^b   Fiorentino, R ^c   McIntyre, M ^d   Huang, Y ^a   Hirschfeld, S ^e  

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

^b GE HEALTHCARE   (United States)

^c CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

^d Biologics Consulting Group Inc   (United States)

^e EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT   (United States)

Author keywords

Cell therapy; Chemistry; Clinical; Food and Drug Administration (FDA); Gene therapy; Hold; Investigational new drugs (IND); Manufacturing and controls (CMC); Office of Cellular; Pre clinical; Tissue and Gene Therapy (OCTGT)

Indexed keywords

NEW DRUG;

ARTICLE; CELL THERAPY; CLINICAL RESEARCH; DRUG DOSE REGIMEN; FOOD AND DRUG ADMINISTRATION; GENE THERAPY; GOVERNMENT REGULATION; PATIENT SAFETY; PRIORITY JOURNAL; RESEARCH SUBJECT; SOMATIC CELL THERAPY; UNITED STATES; BIOLOGICAL THERAPY; CLINICAL TRIAL; DRUG APPROVAL; DRUG SCREENING; HUMAN;

CLINICAL TRIALS AS TOPIC; DRUG EVALUATION, PRECLINICAL; DRUGS, INVESTIGATIONAL; GENE THERAPY; HUMANS; INVESTIGATIONAL NEW DRUG APPLICATION; TISSUE THERAPY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 42449149164     PISSN: 14653249     EISSN: 14772566     Source Type: Journal    
DOI: 10.1080/14653240801910905     Document Type: Article

References (6)

1. Food and Drug Administration, Center for Biologics Evaluation and Research, Rockville, MD. http://www.fda.gov/cber/ind/ind.htm
2. Food and Drug Administration, Center for Biologics Evaluation and Research, Rockville, MD. http://www.fda.gov/cder/regulatory/applications/ ind_page_1.htm
3. Food and Drug Administration, Center for Biologics Evaluation and Research, Rockville, MD. http://www.fda.gov/cber/guidelines.htm
4. Food and Drug Administration, Center for Biologics Evaluation and Research, Rockville, MD. http://www.fda.gov/cber/summaries.htm
5. Food and Drug Administration, Center for Biologics Evaluation and Research, Rockville, MD. http://www.fda.gov/cber/genadmin/ octgtprocess.htm
6. Food and Drug Administration, Center for Biologics Evaluation and Research, Rockville, MD. http://www.fda.gov/cber/gdlns/mtpdufa.htm