Biological products, Apr. 1978-Mar. 1980|RISS 상세보기

목차 (Table of Contents)

CONTENTS
Foreword = ⅲ
How to Use This Book = ⅴ
Ⅰ. General
A. General Provisions = 2

CONTENTS
Foreword = ⅲ
How to Use This Book = ⅴ
Ⅰ. General
A. General Provisions = 2
3. Advertising = 2
3.1 Notice = 2
20.- Biological Drugs Containing Antibiotics = 2
20.1 Final Regulation = 2
50.- Clarifying and Conforming Amendments = 3
50.1 Proposal = 3
50.2 Final Regulation = 3
50.3 Final Regulation = 4
B. Administrative Procedures = 6
5.- Adverse Reactions and Product Experiences = 567
5.1 Availability of Draft Proposal = 567
15.- Dating Periods and Proper Names = 6
15.1 Proposal = 6
15.2 Final Regulation = 7
15.3 Proposal = 7
15.4 Final Regulation = 8
15.5 Proposal = 8
15.6 Final Regulation = 8
15.7 Proposal = 9
15.8 Final Regulation = 9
15.9 Final Regulation = 10
15.10 Final Regulation = 10
15.11 Final Regulation = 11
15.12 Proposal = 568
17.- Public Disclosure of Specifications for Biological Products = 12
17.1 Proposal = 12
18.- Public Information ; Disclosure of Existence = 15
18.1 Proposal = 15
18.2 Extension of Time for Comments = 569
20.- Records and Record Retention = 22
20.1 Proposal = 22
20.2 Final Regulation = 23
25.- Samples = 23
25.1 Final Regulation = 23
30.- Shipping Temperatures = 24
30.1 Proposal = 24
30.2 Final Regulation = 24
32.- Shipping Temperature of Frozen Red Blood Cells = 25
32.1 Proposal = 25
32.2 Final Regulation = 25
35.- Shipping Temperature of Live Measles, Mumps, and Rubella Virus Vaccines = 26
35.1 Proposal = 26
35.2 Final Regultion = 26
37.- Shipping of Whole Blood = 28
37.1 Proposal = 28
37.2 Final Regulation = 28
45.- Storage Requirements for Measles, Mumps, and Rubella Virus Vaccines = 28
45.1 Final Regulation = 28
C. Tests and Methods = 29
15.- Purity Standards = 29
15.1 Proposal = 29
15.2 Final Regulation = 29
20.- Pyrogenic Substances = 30
20.1 Proposal = 30
20.2 Final Regulation = 30
40.- General Safety Test = 35
40.1 Proposal = 35
40.2 Final Regulation = 36
43.- Inactive Influenza Vaccine Safety Test = 43
43.1 Proposal = 43
43.2 Final Regulation = 46
50.- Sterility Requirements = 50
50.1 Proposal = 50
50.2 Final Regulation = 51
50.3 Final Regulation = 570
52.- Sterility Standards for Blood Products = 51
52.1 Final Regulation = 51
52.2 Proposal = 52
54.- Sterility Test and Use of Spore-Bearing Organisms = 52
54.1 Proposal = 52
54.2 Final Regulation = 53
54.3 Final Regulation = 53
57.- Sterility Testing ; Alternative Thloglycollate Medium = 53
57.1 Proposal = 53
57.2 Final Regulation = 54
6O.- Sterility ; Membrane Filtration = 570
60.1 Final Regulation = 570
E .Efficacy Review = 56
3.- General Procedures = 56
3.1 Proposal = 56
3.2 Final Regulation = 57
3.3 Final Regulation = 571
Ⅱ. Labeling Statements and Requirements
B. Blood and Blood Products = 63
7.- Donor Labeling = 63
7.1 Proposal = 63
7.2 Proposal = 69
7.3 Final Regulation = 77
Ⅲ. Licensing, Listing, and Registration
B. Registration and Listings = 88
3.- Registration of Blood Banks = 88
3.1 Proposal = 88
3.2 Final Regulation = 89
3.3 Final Regulation = 93
Ⅳ. Good Manufacturing Practices
A. General = 95
1.- Whole Blood, Red Blood Cells and Allergenic Products = 95
1.1 Proposal = 95
1.2 Final Regulation = 95
B. Good Manufacturing Practice for Blood and Blood Components = 96
3.- Blood and Blood Components = 96
3.1 Proposal = 96
3.2 Final Regulation = 100
3.3 Proposal = 119
3.4 Withdrawal of Proposal = 572
5.- Calibration of Hematocrit Centrifuges and Vacuum Blood Agitators = 573
5.1 Proposal = 573
5.2 Final Regulation = 574
Ⅴ. Biologics for Investigational Use
3.- General Procedures = 121
3.1 Final Regulation = 121
15.- Licensing Requirements for Controlled Investigations = 121
15.1 Final Regulation = 121
Ⅷ. Bacterial Products
A. General = 122
5.- Efficacy Review = 122
5.1 Proposal = 122
5.2 Opportunity for Hearing on Intent to Revoke Licenses = 231
5.3 Final Regulation = 576
B. Tests and Methods = 233
45.- Pertussis Vaccine Safety Test = 233
45.1 Final Regulation = 233
D. Specific Additional Standards for Bacterial Products = 234
5.- Anthrax Vaccine, Adsorbed = 234
5.1 Proposal = 234
5.2 Final Regulation = 234
10.- Cholera Vaccine = 235
10.1 Proposal = 235
10.2 Final Regulation = 236
10.3 Final Regulation = 241
20.- Pertussis Vaccine = 242
20.1 Proposal = 242
20.2 Final Regulation = 242
30.- Typhoid Vaccine = 243
30.1 Proposal = 243
30.2 Final Regulation = 243
30.3 Proposal = 585
Ⅸ. Viral Vaccines
A. General Provisions = 245
5.- Containers = 245
5.1 Proposal = 245
5.2 Final Regulation = 246
10.- Unavoidable Bacteriophage = 246
10.1 Final Regulation = 246
B. Tests and Methods = 248
10.- Live, Attenuated Canine Renal Tissue Cultures = 248
10.1 Proposal = 248
10.2 Final Regulation = 248
10.3 Final Regulation = 248
25.- Monkey Kidney Tissue Culture = 249
25.1 Proposal = 249
25.2 Final Regulation = 250
40.- Measles, Mumps, and Rubella Vaccine Neurovirulence Safety Tests = 251
40.1 Proposal = 251
40.2 Final Regulation = 251
45.- Live Rubella Virus Vaccine Safety Test = 253
45.1 Final Regulation = 253
50.- Poliovirus Vaccine Safety Test = 254
50.1 Final Regulation = 254
65.- Sniallpox Vaccine and Measles-Srnallpox Vaccine Potency and Safety Testing = 255
65.1 Proposal = 255
65.2 Final Regulation = 256
D. Specific Additional Standards for Viral Vaccines = 259
5.- Adenovirus Vaccine = 259
5.1 Proposal = 259
5.2 Final Regulation = 259
5.3 Notice of Opportunity for Hearing = 260
10.- Bacillus of Calmette and Guerin （BCG）Vaccine = 261
10.1 Proposal = 261
10.2 Final Regulation = 587
25.- Measles Virus Vaccine, Live, Attenuated = 262
25.1 Proposal = 262
25.2 Final Regulation = 262
28.- Measles-Smallpox Vaccine, Live = 263
28.1 Proposal = 263
28.2 Final Regulation = 263
28.3 Proposal = 263
28.4 Final Regulation = 265
35.- Mumps Virus Vaccine, Live = 266
35.1 Proposal = 266
35.2 Final Regulation = 266
35.3 Notice = 596
40.- Poliomyelitis Vaccine = 267
40.1 Proposal = 267
40.2 Final Regulation = 267
40.3 Proposal = 268
40.4 Final Regulation = 268
40.5 Final Regulation = 269
40.6 Proposal = 269
40.7 Final Regulation = 269
40.8 Proposal = 270
40.9 Extension of Time for Filing Comments = 270
40.10 Proposal = 270
40.11 Final Regulation = 271
45.- Poliovirus Vaccine, Live, Oral = 271
45.1 Proposal = 271
45.2 Final Regulation = 272
45.3 Proposal = 272
45.4 Final Regulation = 273
45.5 Proposal = 273
45.6 Final Regulation = 274
45.7 Proposal = 274
45.8 Final Regulation = 275
55.- Rubella Virus Vaccine, Live = 275
55.1 Proposal = 275
55.2 Final Regulation = 276
55.3 Proposal = 276
55.4 Final Regulation = 277
60.- Smallpox Vaccine = 277
60.1 Proposal = 277
60.2 Proposal = 277
60.3 Final Regulation = 278
60.4 Final Regulation = 278
Ⅹ. Human Blood and Blood Products
B. Tests and Methods = 281
5.- Blood Grouping Serum = 281
5.1 Proposal = 281
5.2 Amended Proposal = 282
5.3 Final Regulation = 285
5.4 Extension of Effective Date = 300
5.5 Final Regulation ; Correction = 597
10.- Blood Group Substances A, B, and AB = 300
10.1 Proposal = 300
10.2 Final Regulation = 598
35.- Measles Antibody Titer of Globulin Products Replacement Reference = 302
35.1 Final Regulation = 302
41.- Hepatitis Associated（Australia）Antigens = 303
41.1 Proposal = 303
41.2 Final Regulation = 304
41.3 Proposal = 304
41.4 Final Regulation = 307
42.- Hepatitis Associated（Anti-Australia）Antigen = 314
42.1 Proposal = 314
42.2 Final Regulation = 314
42.3 Final Regulation = 315
42.4 Final Regulation = 315
43.- Hepatitis B Surface Antigen = 316
43.1 Notice = 316
43.2 Proposal = 317
43.3 Final Regulation = 600
43.4 Proposal = 601
47.- Syphilis and Hepatitis B Surface Antigen Test = 319
47.1 Final Regulation = 319
50.- Limulus Arnebocyte Lysate = 320
50.1 Notice = 320
50.2 Proposal = 321
50.3 Notice = 322
50.4 Proposal = 603
65.- Leukocyte Typing Serum = 324
65.1 Proposal = 324
65.2 Final Regulation = 325
75.- Reagent Red Blood Cells = 330
75.1 Proposal = 330
75.2 Final Regulation = 332
C. Anticoagulants = 339
15.- Citrate Phosphate = 339
15.1 Proposal = 339
15.2 Final Regulation = 606
15.3 Proposal = 609
D. Specific Additional Standards for Human Blood and Blood Products = 342
5.- Whole Blood = 342
5.1 Proposal = 342
5.2 Final Regulation = 342
5.3 Proposal = 343
5.4 Final Regulation = 343
5.5 Proposal = 343
5.6 Proposal = 344
5.7 Final Regulation = 344
5.8 Amended Proposal = 344
5.9 Final Regulation = 345
5.10 Proposal = 345
5.11 Final Regulation = 346
5.12 Proposal = 346
5.13 Final Regulation = 347
5.14 Proposal = 347
5.15 Final Regulation = 348
10.- Red Blood Cells = 348
10.1 Proposal = 348
10.2 Extension of Time for Comments = 349
10.3 Final Regulation = 349
10.4 Final Regulation = 350
10.5 Final Regulation = 350
15.- Platelet Concentrate = 351
15.1 Proposal = 351
15.2 Proposal = 351
15.3 Final Regulation = 353
15.4 Final Regulation = 360
15.5 Proposal = 610
20.- Single Donor Plasma = 362
20.1 Proposal = 362
20.2 Final Regulation = 364
30.- Cryoprecipitated Antihemophilic Factor = 372
30.1 Proposal = 372
30.2 Final Regulation = 373
30.3 Proposal = 373
30.4 Final Regulation = 375
30.5 Final Regulation = 381
35.- Source Plasma = 382
35.1 Proposal = 382
35.2 Final Regulation = 383
35.3 Proposal = 389
35.4 Notice to Manufacturers = 394
35.5 Final Regulation = 395
35.6 Extension of Effective Date = 409
35.7 Proposal = 410
35.8 Final Regulation = 411
35.9 Notice of Availability of Guideline = 613
35.10 Proposal = 614
40.- Normal Serum Albumin = 413
40.1 Proposal = 413
40.2 Proposal = 414
40.3 Final Regulation = 418
40.4 Extension of Effective Date = 433
45.- Plasma Protein Fraction = 434
45.1 Proposal = 434
50.- Immune Serum Globulin = 434
50.1 Proposal = 434
50.2 Final Regulation = 435
50.3 Notice of Availability of Guidelines = 615
55.- Measles Immune Globulin = 435
55.1 Proposal = 435
55.2 Proposal = 436
55.3 Final Regulation = 436
XI. Diagnostic Substances
A. General = 437
5.- In Vitro Diagnostic Products = 437
5.1 Proposal = 437
5.2 Final Regulation = 439
5.3 Stay of Effective Date = 444
5.4 Extension of Effective Date = 445
B. Dermal Tests = 445
10.- Cancer Testing In Vitro Diagnostic Biologic Substances = 445
10.1 Notice to Manufacturers = 445
20.- Diphtheria Toxin for Schick Test = 446
20.1 Proposal = 446
20.2 Final Regulation = 447
25.- Adsorbed Diphtheria and Tetanus Toxoids = 616
25.1 Notice of Availability of Guideline = 616
40.- Tuberculin = 447
40.1 Proposal = 447
40.2 Final Regulation = 448
40.3 Proposal = 448
40.4 Final Regulation = 449
40.5 Final Regulation = 449
XII. Other Products
B. Allergenic Products = 450
5.- Skin Test Antigen Efficacy Review = 450
5.1 Proposal = 450
5.2 Final Regulation = 617
10.- Allergenic Products = 552
10.1 Proposal = 552
10.2 Final Regulation = 553
12.- Source Material for Allergenic Products = 625
12.1 Proposal = 625
12.2 Extension of Time for Comments = 627
14.- Allergenic Product Multiple Dose Containers = 628
14.1 Proposal = 628
16.- Antigen E Potency Test = 629
l6.1 Proposal = 629
16.2 Extension of Time for Comments = 632
Redesignation Tables = 555,635

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