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-Reference-Cited by-同舟云学术

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

Published:2008 Issue:3 Volume:10 Page:312-316
ISSN:1465-3249
Container-title:Cytotherapy
language:en
Short-container-title:Cytotherapy

Author:

Wonnacott K.,Lavoie D.,Fiorentino R.,McIntyre M.,Huang Y.,Hirschfeld S.

Publisher

Elsevier BV

Subject

Cancer Research,Transplantation,Cell Biology,Genetics(clinical),Oncology,Immunology,Immunology and Allergy

Reference6 articles.

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.

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