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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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120 rows where docket_id = "FDA-1995-N-0063" sorted by posted_date descending

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id agency_id docket_id title document_type subtype posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
FDA-1995-N-0063-0147 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 60 Infant Formula Act of 1980 Report by the Committee on Labor and Human Resources United States Senate Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T14:40:06Z   0 0 090000648172d7c7
FDA-1995-N-0063-0145 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 57 Jensen and Jensen Invited Review Specialty Lipids for Infant Nutrition I. Milks and Formulas Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T14:36:38Z   0 0 090000648172d7c4
FDA-1995-N-0063-0169 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 81 Minton et al Bone Mineral Content in Term and Preterm Appropriate-for-Gestational-Age Infants Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T16:06:53Z   0 0 090000648174e748
FDA-1995-N-0063-0159 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 58 Ziegler et al Cow Milk Feeding in Infancy: Further Observations on Blood Loss from the Gastrointestinal Tract Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T15:54:21Z   0 0 090000648172d7c5
FDA-1995-N-0063-0140 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 52 Summary of Findings Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T14:31:12Z   0 0 090000648172d7b5
FDA-1995-N-0063-0155 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 69 Shenai et al Nutritional Balance Studies in Very Low-Birth- Weight Infants: Role of Soy Formula Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T15:47:32Z   0 0 090000648172de15
FDA-1995-N-0063-0156 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 70 Lindroth et al Rickets in Very Low Birthweight Infants Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T15:48:27Z   0 0 090000648172de16
FDA-1995-N-0063-0176 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 88 Memorandum of Telephone Conversation between Ed puro, FDA, and Mary Hudtloff Dated March 15, 1994 Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T16:11:06Z   0 0 090000648174e74f
FDA-1995-N-0063-0160 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 66 Koletzko et al Intestinal Milk - Bolus Obstruction in Formula-Fed Premature Infants Given High Doses of Calcium Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T15:54:29Z   0 0 090000648172de12
FDA-1995-N-0063-0158 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 72 FDA Guideline for the Format and Content of the Clinical and Statistical Sections of New Drug Applications Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T15:50:34Z   0 0 090000648172de18
FDA-1995-N-0063-0146 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 59 Committee on Nutrition Commentary on Breast-Feeding and Infant Formulas, Including Proposed Standards for Formulas Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T14:38:37Z   0 0 090000648172d7c6
FDA-1995-N-0063-0168 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 80 Ryan et al Phosphate, Alkaline Phosphatase and Bone Mineralization in Preterm Neonates Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T16:06:09Z   0 0 090000648174e747
FDA-1995-N-0063-0151 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 64 Samuel J. Fomon, M.D. Nutrition of Normal Infants Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T15:36:36Z   0 0 090000648172de10
FDA-1995-N-0063-0166 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 75 Moore and Roche Pediatric Anthropometry 2nd Edition Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T16:02:05Z   0 0 090000648174e567
FDA-1995-N-0063-0163 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 77 Sarwar et al Difference in Protein Digestibility and Quality of Liquid Concentrate and Powder Forms of Milk-Baed Infant Formulas Fed to Rats Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T15:59:42Z   0 0 090000648174e744
FDA-1995-N-0063-0165 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 79 Fomon and Nelson Calcium, Phoshorus, Magnesium, and Sulfur Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T16:01:39Z   0 0 090000648174e746
FDA-1995-N-0063-0177 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 89 Memorandum of Telephone Conversation between Ed Puro, FDA, and Lorena, Hazleton Labs Dated March 17, 1993 Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T16:11:35Z   0 0 090000648174e750
FDA-1995-N-0063-0144 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 56 Jensen et al Lipids of Human Milk and Infant Formulas: A Review Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T14:35:40Z   0 0 090000648172d7c3
FDA-1995-N-0063-0141 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 53 Internal FDA Memo dated May 12, 1994 Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T14:32:07Z   0 0 090000648172d7b6
FDA-1995-N-0063-0149 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 62 Hallberg et al Bioavailability in Man of Iro in Human Milk and Cow's Milk in Relation to Their Calcium Contents Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T15:35:08Z   0 0 090000648172d3be
FDA-1995-N-0063-0154 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 68 Moya et al Short-Term polcose Substitution for Lactose Reduces Calcium Absorption in Healthy Term Babies Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T15:46:45Z   0 0 090000648172de14
FDA-1995-N-0063-0171 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 83 Gary M. Chan Performance of Dual Energy X-Ray Absorptiometry in Evaluatiing Bone, Lean Body Mass, and Fat in Pediatric Subjects Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T16:07:57Z   0 0 090000648174e74a
FDA-1995-N-0063-0172 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 84 Braillon et al Dual energy X-Ray Absorptiometry Measurements of bone mineral Content in Newborns: Validation of the Technique Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T16:08:29Z   0 0 090000648174e74b
FDA-1995-N-0063-0173 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 85 Salle and Glorieux Assessment of Bone Mineral Content in Infants: The New Age Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T16:08:59Z   0 0 090000648174e74c
FDA-1995-N-0063-0174 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 86 Samuel J. Fomon Nutrition of Normal Infants Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T16:09:38Z   0 0 090000648174e74d
FDA-1995-N-0063-0157 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 71 Chan and Mileur Posthospitalization Growth and Bone Mineral Status of Normal Preterm Infants Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T15:49:19Z   0 0 090000648172de17
FDA-1995-N-0063-0142 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 54 Tanner et al Analysis of Milk-Based Infant Formula Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T14:33:22Z   0 0 090000648172d7c0
FDA-1995-N-0063-0162 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 74 Roche et al Weight and Recumbent Lenght from 1 to 12 Mo of Age: Refenece DAta for 1-mo Increments Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T15:56:14Z   0 0 090000648174e566
FDA-1995-N-0063-0167 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 76 Behrman et al Nelson Textbook of Pediatrics 14th Edition Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T16:02:12Z   0 0 090000648174e568
FDA-1995-N-0063-0164 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 78 Rudloff and Lonnerdal Solubility and Digestibility of Milk Proteins in Infant Formmulas Exposed to Different Heat Treatments Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T16:00:32Z   0 0 090000648174e745
FDA-1995-N-0063-0170 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 82 Steichen et al Bone Mineral Content Measurement in Small Infants by Single-Photon Absorptiometry: Cureent Methodologic Issues Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T16:07:24Z   0 0 090000648174e749
FDA-1995-N-0063-0148 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 61 Saarinen et al Iron Absorption in Infants: High Bioavailability of Breast milk Iron as Indicated by the Extrinsic Tag Method of Iron Absorption and by the Concentration of Serum Ferritin Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T15:25:25Z   0 0 090000648172d3bd
FDA-1995-N-0063-0150 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 63 Derman et al Factors Influencing the Absorption of Iron from Soya-Bean Protein Products Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T15:35:46Z   0 0 090000648172de0f
FDA-1995-N-0063-0161 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 73 Lewis A. Barness Pediatric Nutrition Handbook 3rd Edition Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T15:55:22Z   0 0 090000648174e565
FDA-1995-N-0063-0152 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 65 Steichen et al Osteopenia of Prematurity: The Cause and Possible Treatment Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T15:44:26Z   0 0 090000648172de11
FDA-1995-N-0063-0178 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 90 Incorporated by Reference to Federal Register Notice Published July 9, 1996 Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T16:12:36Z   0 0 090000648174e751
FDA-1995-N-0063-0153 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 67 Ziegler and Fomon Lactose Enhances Mineral Absorption in Infancy Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T15:46:01Z   0 0 090000648172de13
FDA-1995-N-0063-0175 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 87 Carlson et al First Year Growth of Preterm Infants Fed Standard Compared to Marine Oil n-3 Supplemented Formula Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T16:10:19Z   0 0 090000648174e74e
FDA-1995-N-0063-0143 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 55 Southgate et al Nutrient Availability: Chemical and Biological Aspects Supporting & Related Material Background Material 2014-07-17T04:00:00Z 2014 7     2014-07-17T14:34:10Z   0 0 090000648172d7c2
FDA-1995-N-0063-0100 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Attachment C Industry Proposal on Infant Formula Powder Labeling Comment International Formula Council Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:08:04Z   0 0 090000648056cb93
FDA-1995-N-0063-0089 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Attachment A Suggested Language Comment from International Formula Council Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:04:32Z   0 0 090000648056cb68
FDA-1995-N-0063-0096 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Attachment on Basis and Context of Sample Growth Trial Protocol Comment from International Formula Council Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:06:25Z   0 0 090000648056cb75
FDA-1995-N-0063-0114 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 26 No Material Submitted Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:24:11Z   0 0 090000648172d766
FDA-1995-N-0063-0117 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 29 Ronald F Tetzlaff GMP Documentation Requirements for Automated Systems Part 1 Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:25:23Z   0 0 090000648172d769
FDA-1995-N-0063-0121 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 33 Salmonella Ealing Inspections Associated with Consumption of Infant Dired Milk Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:27:41Z   0 0 090000648172d770
FDA-1995-N-0063-0133 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 45 Jackson et al Control of Salmonellosis and Similar Foodborne Infections Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:38:31Z   0 0 090000648172d7aa
FDA-1995-N-0063-0115 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 27 IEEE Standard Glossary of Software Engineering Terminology Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:24:39Z   0 0 090000648172d767
FDA-1995-N-0063-0125 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 37 Farber and Peterkin Listeria Monocytogenes A Food Borne Pathogen Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:33:51Z   0 0 090000648172d7a2
FDA-1995-N-0063-0119 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 31 Ronald F Tetzlaff GMP Documentation Requirements for Automated Systems Part 3, FDA Inspections of Computerized Laboratory Systems Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:26:09Z   0 0 090000648172d76e
FDA-1995-N-0063-0093 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Attachment E Letter from IFC to FDA CFSAN dated July 7 2003 Comment from International Formula Council Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:05:35Z   0 0 090000648056cb6f
FDA-1995-N-0063-0103 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Attachment F Letter from Douglas L Archer to International Formula Council Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:03:17Z   0 0 090000648056cb8b
FDA-1995-N-0063-0086 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Withdrawal of Comments from International Formula Council Other Withdrawal 2014-07-16T04:00:00Z 2014 7 2014-07-16T04:00:00Z   2014-07-17T16:30:30Z   0 0 090000648056cbd3
FDA-1995-N-0063-0095 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Attachment G Guidelines Concerning Notification and Testing of Infant Formulas Comment from International Formula Council Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:06:06Z   0 0 090000648056cb73
FDA-1995-N-0063-0107 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Appendix A3 Comment from International Formula Council Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:14:16Z   0 0 090000648056cc22
FDA-1995-N-0063-0136 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 48 Harmon and Kautter Incidence and Growth Potential of Bacillus cerues in Ready-to Serve Foods Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:46:11Z   0 0 090000648172d7af
FDA-1995-N-0063-0124 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 36 Paul G. Quie Antimicrobial Defenses in the Neonante Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:33:28Z   0 0 090000648172d773
FDA-1995-N-0063-0127 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 39 Abram S. Benenson Control of Communicable Diseases in Man Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:34:37Z   0 0 090000648172d7a4
FDA-1995-N-0063-0135 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 47 Robert T. Marshall Standard Methods for the Examination of Dairy Products Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:45:36Z   0 0 090000648172d7ae
FDA-1995-N-0063-0134 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 46 FDA Bacteriological Analytical Manual 7th Edition 1992 Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:45:18Z   0 0 090000648172d7ad
FDA-1995-N-0063-0091 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Attachment C Industry Proposal on Infant Formula Powder Labeling Comment from International Formula Council Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:05:02Z   0 0 090000648056cb6c
FDA-1995-N-0063-0098 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Attachment A International Formula Council Suggested Language Comment International Formula Council Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:06:58Z   0 0 090000648056cb97
FDA-1995-N-0063-0094 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Attachment F Letter from Douglas L Archer to IFC Comment from International Formula Council Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:05:51Z   0 0 090000648056cb71
FDA-1995-N-0063-0109 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 6 American Academy of Pediatrics Clinical Testing of Infant Formulas with Respect to Nutritional Suitability for Team Infants Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:20:33Z   0 0 090000648172d722
FDA-1995-N-0063-0120 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 32 Letter from Infant Formula Council to FDA Dated March 31, 1993 Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:26:48Z   0 0 090000648172d76f
FDA-1995-N-0063-0122 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 34 Letter from Infant Formula Council to FDA Dated June 24, 1993 Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:28:24Z   0 0 090000648172d771
FDA-1995-N-0063-0137 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 49 FDA / CFSAN Draft of Microbiological Evaulation of Powdered Infant Formula Prepared by David A. Golden, Ph.D. Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:46:51Z   0 0 090000648172d7b2
FDA-1995-N-0063-0112 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 9 Infant Formula Council Recommended Current Good Manufacturing Practice for Infant Formula Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:22:32Z   0 0 090000648172d725
FDA-1995-N-0063-0113 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 25 Guidelines on Sterile Drug Products Produced by Aseptic Processing dated June 1987 Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:23:30Z   0 0 090000648172d765
FDA-1995-N-0063-0123 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 35 Michael P. Doyle Foodborne Bacterial Pathogens Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:33:04Z   0 0 090000648172d772
FDA-1995-N-0063-0126 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 38 Listeria Monocytogenes Recommendations by the National Advisory Committee on Microbiological criteria for Foods Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:34:15Z   0 0 090000648172d7a3
FDA-1995-N-0063-0128 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 40 Balows et al Laboratory Diagnosis of Infectious Diseases Principles and Pratice Volume 1 Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:34:59Z   0 0 090000648172d7a5
FDA-1995-N-0063-0130 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 42 Schwab et al Microbiological Quality of Dry-Milk Mixes and Milk Substitute Infant Formulas Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:37:26Z   0 0 090000648172d7a7
FDA-1995-N-0063-0092 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Attachment D Proposed Discussion Points on Powdered Infant Comment from International Formula Council Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:05:21Z   0 0 090000648056cb6e
FDA-1995-N-0063-0105 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Appendix A1 Comment from International Formula Council Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:12:53Z   0 0 090000648056cc19
FDA-1995-N-0063-0108 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Appendix B Comment from International Formula Council Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:15:56Z   0 0 090000648056cc1c
FDA-1995-N-0063-0085 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Correction from International Formula Council Other Correction(s) 2014-07-16T04:00:00Z 2014 7 2014-07-16T04:00:00Z   2014-07-16T13:57:23Z   0 0 090000648056cbcd
FDA-1995-N-0063-0090 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Attachment B FDA Infant Formula GMP Regulation Comment from International Formula Council Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:04:48Z   0 0 090000648056cb6a
FDA-1995-N-0063-0102 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Attachment E Letter from IFC to FDA/CFSAN dated July 7 2003 Comment from International Formula Council Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:01:32Z   0 0 090000648056cb90
FDA-1995-N-0063-0097 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Attachment L Decision Tree Chart for Documentation of Nutritional Adequacy of a New or Changed Infant Formula Comment from International Formula Council Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:06:39Z   0 0 090000648056cb79
FDA-1995-N-0063-0106 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Appendix A2 Comment from International Formula Council Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:12:14Z   0 0 090000648056cc1b
FDA-1995-N-0063-0129 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 41 Chapter 2 Microorganisms in Foods Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:35:21Z   0 0 090000648172d7a6
FDA-1995-N-0063-0131 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 43 Collins-Thompson et al Microbiological Guidelines and Sampling Plans for Dried Infant Cereals and Powdered Infant Formula from a Canadian National Microbiological Survey Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:37:47Z   0 0 090000648172d7a8
FDA-1995-N-0063-0104 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Attachment L Decision Tree Chart for Documentation of Nutritional Adequacy of a New or Changed Infant Formula Comment from International Formula Council Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:03:51Z   0 0 090000648056cb9d
FDA-1995-N-0063-0110 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 7 Congressional Record House Vol 126 Dated May 20, 1980 Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:21:12Z   0 0 090000648172d723
FDA-1995-N-0063-0111 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 8 Guidelines Concerning Notification and Testing of Infant Formulas Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:21:54Z   0 0 090000648172d724
FDA-1995-N-0063-0116 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 28 FDA Glossary of Computerized System and Software Development Terminology August 1995 Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:25:05Z   0 0 090000648172d768
FDA-1995-N-0063-0118 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 30 Ronald F Tetzlaff GMP Documentation Requirements for Automated Systems Part 2 Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:25:47Z   0 0 090000648172d76a
FDA-1995-N-0063-0101 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Attachment D Proposed Discussion Points on Powdered Infant Comment from International Formula Council Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:08:23Z   0 0 090000648056cb91
FDA-1995-N-0063-0099 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Attachment B FDA Infant Formula GMP Regulation Comment from International Formula Council Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:07:48Z   0 0 090000648056cb9f
FDA-1995-N-0063-0132 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 44 FDA Enforcement Report dated July, 14 1993 Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:38:07Z   0 0 090000648172d7a9
FDA-1995-N-0063-0138 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 50 FDA Consumer October 1988 Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:47:21Z   0 0 090000648172d7b3
FDA-1995-N-0063-0139 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 51 Memorandum of Record dated June 25, 1996 Supporting & Related Material Background Material 2014-07-16T04:00:00Z 2014 7     2014-07-16T16:47:48Z   0 0 090000648172d7b4
FDA-1995-N-0063-0077 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula; Correction Rule Correction 2014-07-15T04:00:00Z 2014 7 2014-07-15T04:00:00Z   2014-07-15T14:43:19Z 2014-16476 0 0 09000064817ad884
FDA-1995-N-0063-0061 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Comment from Jason and Jarvis Associates, LLC re FDA-1995-N-0063-0058 Supporting & Related Material Background Material 2014-07-09T04:00:00Z 2014 7     2014-07-09T15:32:46Z   0 0 090000648167063e
FDA-1995-N-0063-0051 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 1 - FDA. Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula. Regulatory Impact Analysis for Final Rule - Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula Supporting & Related Material Background Material 2014-06-10T04:00:00Z 2014 6     2014-06-10T20:26:38Z   0 0 09000064817368eb
FDA-1995-N-0063-0052 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference - 1-1 Zink, Don. Statement of Donald L. Zink, Ph. D.: Infant Formula Manufacturing Practices, 2013 - Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula Supporting & Related Material Background Material 2014-06-10T04:00:00Z 2014 6     2014-06-10T20:26:49Z   0 0 09000064817368ed
FDA-1995-N-0063-0050 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 List of References Supporting & Related Material Background Material 2014-06-10T04:00:00Z 2014 6     2014-06-10T19:00:18Z   0 0 09000064817368ec
FDA-1995-N-0063-0053 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 1-2 - Silverman, B. Statement of Benson M. Silverman, M.D. "Industry Efforts to Meet Quality Factor Requirements," 2013 - Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula Supporting & Related Material Background Material 2014-06-10T04:00:00Z 2014 6     2014-06-10T20:27:04Z   0 0 09000064817368ee
FDA-1995-N-0063-0054 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Reference 1-3 - Dickinson, D.L. and R.L. Verbeek. "Wage Differentials Between College Graduates With and Without Learning Disabilities - Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula Supporting & Related Material Background Material 2014-06-10T04:00:00Z 2014 6     2014-06-10T20:27:20Z   0 0 09000064817368ef
FDA-1995-N-0063-0049 FDA CGMPs for the Production of Infant Formula FDA-1995-N-0063 Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula Rule Final Rule 2014-06-10T04:00:00Z 2014 6 2014-06-10T04:00:00Z 2014-07-11T03:59:59Z 2014-07-03T01:01:55Z 2014-13384 0 0 0900006481734cd4

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