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Chapter 96  Investigational New Drug–Enabling Processes for Cell-Based Therapies  1536.e1

            REFERENCES                                            13.  US  Food  and  Drug  Administration,  Center  for  Drug  Evaluation  and
                                                                     Research, Center for Biologics Evaluation and Research: Formal meetings
             1.  Title 21 Code of Federal Regulations: Part 211 Current good manufactur-  between the FDA and sponsors or applicants of PDUFA products, March
               ing practice for finished pharmaceuticals, April 2011.  2015.
             2.  Title 21 Code of Federal Regulations: Part 1271 Human cells, tissues, and   14.  US Food and Drug Administration, Center for Biologics Evaluation and
               cellular and tissue-based products May 25, 2005.      Research:  SOPP  8101.1—Scheduling  and  conduct  of  regulatory  review
             3.  Burger  S:  GTP/GMP  cell  engineering  for  cell  and  gene  therapies.   meetings with sponsors and applicants, Version 5, October 15, 2012.
               BioProcess J 2:1–4, 2003.                          15.  US Food and Drug Administration, Center for Biologics Evaluation and
             4.  Guidance for Industry: Potency tests for cellular and gene therapy products,   Research  Guidance  for  FDA  Review  Staff  and  Sponsors:  Content  and
               January 2011.                                         review  of  chemistry,  manufacturing,  and  control  (CMC)  information  for
             5.  US  Pharmacopeia:  <1046>  General  information  chapter,  cell  and  gene   human gene therapy investigational new drug applications (INDs), April 9,
               therapy products, United States, Rockville, MD, March 2002.  2008.
             6.  Guidance for Industry: Source Animal, Product, Preclinical, and Clinical   16.  Title 21 Code of Federal Regulations: Part. 312.23, IND content and
               Issues Concerning the Use of Xenotransplantation Products in Humans: Final   format, 2005.
               Guidance, April 2003.                              17.  US  Food  and  Drug  Administration,  Center  for  Biologics  Evaluation
             7.  Brandenberger R, et al: Integrating process and product development for the   and Research: SOPP 8201 – Administrative processing of clinical holds for
               next generation of biotherapeutics. BioProcess International, March, 2011.  investigational new drug applications, Version 4, May 19, 2014.
             8.  US Food and Drug Administration, Center for Biologics Evaluation and   18.  Title 21 Code of Federal Regulations: Tracking from donor to consignee
               Research: References  for  the  Regulatory  Process  for  the  Office of Cellular,   or final disposition, Part 1271.290(e), May 2005.
               Tissue and Gene Therapies (OCTGT), February 03, 2015.  19.  Title 49 Code of Federal Regulations: Hazardous materials regulations,
             9.  US Food and Drug Administration: FDA history. <http://www.fda.gov/  Part 171, 2007.
               oc/history/> (Date Accessed 4.06.15).              20.  Whiteside  TL,  Griffin  DL,  Stanson  J,  et al:  Shipping  of  therapeutic
            10.  Title 21 Code of Federal Regulations: Part 1271 Human Cells, Tissues,   somatic cell products. Cytotherapy 13:201, 2011.
               and Cellular and Tissue-Based Products, May 25, 2005.  21.  Lindblad  RW,  Ibenana  L,  Wagner  JE,  et al:  Cell  therapy  product
            11.  US Food and Drug Administration, Center for Biologics Evaluation and   administration and safety: data capture and analysis from the Production
               Research: About CBER, March 2015.                     Assistance for Cellular Therapies (PACT) program. Transfusion 55:674,
            12.  US  Food  and  Drug  Administration,  Center  for  Biologics  Evaluation   2015.
               and  Research:  Information  on  submitting  an  investigational  new  drug
               application, March 2015.
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