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1
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0345424863
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Guidance for Industry
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Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications, October 20.
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Guidance for Industry. Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications, October 20, 2009.
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(2009)
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2
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77953663577
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Draft Guidance for Industry and FDA Staff
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Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications. October 20, 2009
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Draft Guidance for Industry and FDA Staff. Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications. October 20, 2009.
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3
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78650655591
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A Proposed Approach to Regulation of Cellular and Tissue-Based Products (62 FR 9721, March 4, 1997).
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A Proposed Approach to Regulation of Cellular and Tissue-Based Products (62 FR 9721, March 4, 1997).
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4
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78650654149
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21 CFR 1271.
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21 CFR 1271.
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5
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78650656747
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Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing (66 FR 5447), January 19, 2001.
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Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing (66 FR 5447), January 19, 2001.
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6
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78650666089
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May 25, 2004. Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (69 FR 29786).
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May 25, 2004. Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (69 FR 29786).
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7
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78650647154
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November 24, Current Good Tissue Practice for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products; Inspection and Enforcement (69 FR 68612).
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November 24, 2004. Current Good Tissue Practice for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products; Inspection and Enforcement (69 FR 68612).
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(2004)
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8
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78650655592
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1 CFR Part 601.
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1 CFR Part 601.
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9
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78650673998
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Guidance for Industry
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Guidance for Industry, p. 2.
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10
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78650656043
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Section 361 of the Public Health Service Act, (42 U.S.C. 264).
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Section 361 of the Public Health Service Act, (42 U.S.C. 264).
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11
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78650673488
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21 CFR Parts 201, and 610.
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21 CFR Parts 201, and 610.
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12
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78650633167
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21 CFR Part 202.
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21 CFR Part 202.
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13
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78650673732
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21 CFR Parts 210 and 211.
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21 CFR Parts 210 and 211.
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14
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78650662036
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21 CFR Part 600.
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21 CFR Part 600.
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15
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78650661579
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21 CFR 312.8.
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21 CFR 312.8.
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16
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