1102:
964:
570:(CDER) were split into their present form. The two groups were charged with enforcing different laws and had significantly different philosophical and cultural differences. CBER took a more collaborative, public-health driven approach to working with the industry, and in the 1980s was quicker to approve products than their drugs counterparts. The growing crisis around
457:
to make and enforce regulations to control the interstate spread of communicable disease. This broad authority has been delegated to the FDA through a
Memorandum of Understanding. Many of the products overseen by CBER are also considered drugs, and are subject to the same rules and regulations as any
584:
In 2002, the FDA transferred a number of biologically produced therapeutics to CDER. CBER regulates a number of biologics-related products, including blood tests, computer software, and devices related to blood transfusion, which industry representatives would like to see handled by the much brisker
472:
In addition to these laws and guidelines, CBER also publishes guidance documents. These are not requirements, but are generally followed by industry. Licensed manufacturers are expected to adopt either the guidance or an equivalent process. In some cases, the guidance documents have the force of
450:. CBER may deny licensure or suspend or cancel a current license if a manufacturer does not comply with requirements. Unlicensed blood products used within the boundaries of a state are not unusual, and these products are subject to general regulations from other FDA legal authorities.
67:
421:
Historically, CBER was responsible for some therapeutic proteins, such as monoclonal antibodies. Control of these has been transferred to CDER. Some other drugs, such as certain anticoagulants and plasma volume expanders remain under the control of
1355:
53:
593:
Federal law and DHS policy define the procedures for the CBER to establish advisory committees, which may further be divided into panels and must be renewed every two years. As of 2018 the FDA has 31 advisory committees.
574:
testing and treatment, and an inter-agency dispute between officials from the former Bureau of Drugs and officials from the former Bureau of
Biologics over whether to approve Genentech's Activase (
2564:
581:
In 1997, Congress re-authorized user fees, and research previously done at taxpayer expense began to be charged to manufacturers. CBER's research work has diminished dramatically since then.
2554:
509:
According to numbers from the FDA, in 2001 the CBER reviewed 16 Biologics
License Applications (BLAs) with a median review time of 13.8 months and a median approval time of 20.3 months.
2569:
1121:
1024:
755:
McDonald, Sharon. (September 2002) "Science and the
Regulation of Biological Products: From a Rich History to a Challenging Future." Center for Biologics Evaluation and Research.
256:
638:
578:), led to the split. CBER was declared the primary agency for HIV/AIDS-related products, since HIV had been spread significantly by blood transfusion and related products.
2524:
2429:
1116:
1091:
819:"Transcript of U.S. FDA Center for Biologics Evaluation and Research Vaccines and Related Biological Products Advisory Committee's 101st meeting of February 16, 2005"
465:. Most of the regulations specific to CBER are found from 21CFR600-680. 21CFR1271 contains the rules for HCT/Ps. For products which are also drugs, such as blood for
60:
1577:
1056:
2539:
1466:
1340:
469:, rules in 21CFR200 and following apply. Other general rules, such as the regulations for clinical trials involving human subjects in 21CFR50, may also apply.
1617:
1612:
1066:
311:
1350:
1162:
462:
2544:
1081:
1017:
556:
1379:
843:
818:
386:
Human cells, tissues, and cellular and tissue-based products (HCT/Ps), except vascularized organs for transplantation and the associated blood vessels.
2534:
736:
914:
2574:
2009:
1061:
567:
347:
1627:
547:, the line between a drug and a biologic, or a device and a biologic, became blurred. It was merged with the FDA's Bureau of Drugs to form the
482:
2529:
2480:
2408:
1010:
2014:
996:
1126:
454:
2549:
2046:
1729:
1582:
497:
CBER's
Vaccines and Related Biological Products Advisory Committee meets annually for a discussion and vote concerning the next year's
2456:
1798:
1768:
1401:
1186:
362:
for transfusion and as a raw material for drug products, as well as reagents used for blood typing and other related activities -and-
1868:
1131:
1086:
489:. The FDA uses this software to analyze data on adverse reactions to vaccines and other biological, in order to improve regulation.
765:
2435:
1410:
790:
2019:
2559:
2056:
2024:
1853:
1803:
989:
2114:
1724:
1368:
1136:
1076:
563:
629:
Bone, Reproductive and
Urologic Drugs Advisory Committee – formerly called the Reproductive Health Drugs Advisory Committee
1912:
1622:
1229:
601:
in 2020, the
Vaccines and Related Biological Products Advisory Committee (VRBPAC) received media attention as it reviewed
526:
291:
The present center can trace its history back to the original
American public health service, which later became the NIH.
1219:
1033:
575:
307:
270:
237:
413:, tests used to screen blood donations, blood bank collection machines and equipment, and blood bank computer software.
2497:
1071:
436:
2034:
1476:
1459:
1274:
367:
555:. This reorganization similarly merged the bureaus responsible for medical devices and radiation control into the
2084:
1345:
1214:
432:
2039:
2004:
1999:
1994:
544:
319:
2485:
2418:
2399:
2195:
2167:
2129:
2124:
2104:
1632:
1204:
847:
826:
620:
Antimicrobial Drugs
Advisory Committee (AMDAC) – formerly called the Anti-Infective Drugs Advisory Committee
315:
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218:
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1394:
1141:
2461:
2295:
2290:
1746:
1692:
1602:
1299:
522:
343:
31:
442:
Section 351 of the Public Health
Service Act requires licensure of biological products that travel in
381:
Blood and blood products activities are managed through the Office of Blood Research and Review (OBRR)
2344:
2285:
2076:
1719:
1597:
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1515:
1449:
1254:
371:
1002:
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2233:
2119:
1885:
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1454:
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552:
416:
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2134:
1875:
1841:
1826:
1702:
1672:
1592:
1510:
1249:
1244:
861:
Kim Coghill (16 December 2002). "ZOON RESIGNS POSITION AT CBER, PLANS MOVE TO CANCER INSTITUTE".
529:, rather than the FDA. Its mission included a mandate to foster the development of new vaccines.
461:
From these legal authorities, CBER publishes regulations which are included in the first chapter
973:
318:, M.D., PhD. CBER is responsible for assuring the safety, purity, potency, and effectiveness of
2423:
2390:
2369:
2223:
2064:
1954:
1848:
1709:
1534:
1497:
1387:
1234:
598:
498:
466:
2349:
2334:
2190:
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1964:
1304:
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1239:
1174:
602:
2354:
2152:
1959:
1917:
1788:
1758:
1741:
1667:
1657:
1587:
1526:
1522:
1471:
1294:
1209:
443:
969:
2491:
2218:
2109:
2069:
1949:
1775:
1714:
1314:
1289:
1284:
1259:
1224:
723:
Transmissible Spongiform Encephalopathies Advisory Committee – terminated June 9, 2016
2518:
2374:
2359:
2329:
2324:
2179:
1942:
1937:
1932:
1927:
1836:
1682:
1481:
1324:
1309:
1264:
1037:
447:
331:
900:
Reid, Ken. "CBER and CDER have long history of being lumped together and split up."
2451:
2094:
1989:
1922:
1863:
1687:
1543:
1434:
1414:
1356:
Regulation of food and dietary supplements by the U.S. Food and Drug Administration
1319:
537:
363:
339:
335:
17:
532:
The Bureau was transferred from the NIH to the FDA in 1972, where it was renamed
2238:
2228:
2089:
1895:
1890:
1808:
1783:
1751:
1677:
1539:
1430:
1422:
518:
486:
2364:
2339:
2029:
1979:
695:
Science Advisory Board (SAB) to the National Center for Toxicological Research
2413:
1984:
1857:
1426:
403:
375:
327:
701:
Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC)
2255:
2248:
2243:
2213:
1969:
1905:
1900:
396:
231:
Became part of the newly formed Public Health and Marine Hospital Service
431:
As of July 2006 CBER's authority resides in sections 351 and 361 of the
1974:
1736:
1418:
389:
323:
726:
Veterinary Medicine Advisory Committee – terminated September 24, 2013
2277:
2262:
1553:
707:
Vaccines and Related Biological Products Advisory Committee (VRBPAC)
680:
Pharmaceutical Science and Clinical Pharmacology Advisory Committee
2272:
2157:
1763:
1697:
662:
National Mammography Quality Assurance Advisory Committee (NMQAAC)
359:
717:
Antiviral Drugs Advisory Committee – terminated February 15, 2015
1572:
1383:
1006:
473:
regulation because they are written to clarify existing rules.
677:
Peripheral and Central Nervous System Drugs Advisory Committee
644:
Device Good Manufacturing Practice Advisory Committee (DGMPAC)
571:
410:
283:
Split to form the Center for Biologics Evaluation and Research
36:
458:
other drug product from the Food, Drug, and Cosmetic Act.
617:
Anesthetic and Analgesic Drug Products Advisory Committee
551:
during an agency-wide reorganization under Commissioner
346:
and other therapeutic proteins are regulated by the FDA
635:
Cellular, Tissue, and Gene Therapies Advisory Committee
770:
About the Center for Biologics Evaluation and Research
766:"Director, Office of Blood Research and Review (OBRR)"
720:
Food Advisory Committee – terminated December 12, 2017
704:
Tobacco Products Scientific Advisory Committee (TPSAC)
525:
of 1902. Originally, CBER was part of what became the
656:
Medical Devices Advisory Committee (MDAC) – 18 panels
650:
Endocrinologic and Metabolic Drugs Advisory Committee
342:
therapies). Not all biologics are regulated by CBER.
639:
Dermatologic and Ophthalmic Drugs Advisory Committee
521:, a vaccine-contamination scandal that prompted the
2444:
2383:
2315:
2206:
2178:
2145:
1819:
1650:
1643:
1562:
1490:
1442:
1333:
1197:
1181:
1169:
1157:
1150:
1109:
1044:
915:"Advisory Committee Laws, Regulations and Guidance"
2565:Medical and health organizations based in Maryland
647:Drug Safety and Risk Management Advisory Committee
2430:Cedillo v. Secretary of Health and Human Services
1163:Title 21 of the Code of Federal Regulations (CFR)
1117:Family Smoking Prevention and Tobacco Control Act
1092:Office of Global Regulatory Operations and Policy
698:Science Board to the Food and Drug Administration
632:Cardiovascular and Renal Drugs Advisory Committee
409:Some medical devices, specifically test kits for
2555:Medical research institutes in the United States
939:. Food and Drug Administration. 29 November 2018
245:Division of Biologics Control formed within NIH
2570:Pharmaceutical regulation in the United States
485:was based on a data integration platform from
1395:
1341:Criticism of the Food and Drug Administration
1018:
975:Center for Biologics Evaluation and Research
917:. Food and Drug Administration. 27 March 2018
614:Allergenic Products Advisory Committee (APAC)
278:Merged to form Center for Drugs and Biologics
61:
8:
1067:Center for Food Safety and Applied Nutrition
1052:Center for Biologics Evaluation and Research
686:Psychopharmacologic Drugs Advisory Committee
585:Center for Devices and Radiological Health.
312:U.S. Department of Health and Human Services
300:Center for Biologics Evaluation and Research
1351:History of the Food and Drug Administration
1187:Title 21 of the United States Code (U.S.C.)
543:Ten years later, with the beginning of the
463:Title 21 of the Code of Federal Regulations
30:"CBER" redirects here. For other uses, see
1647:
1402:
1388:
1380:
1154:
1082:National Center for Toxicological Research
1057:Center for Devices and Radiological Health
1025:
1011:
1003:
689:Pulmonary-Allergy Drugs Advisory Committee
557:Center for Devices and Radiological Health
68:
54:
737:Risk Evaluation and Mitigation Strategies
653:Gastrointestinal Drugs Advisory Committee
2525:1902 establishments in the United States
665:Nonprescription Drugs Advisory Committee
659:Medical Imaging Drugs Advisory Committee
626:Blood Products Advisory Committee (BPAC)
1062:Center for Drug Evaluation and Research
896:
894:
892:
748:
683:Pharmacy Compounding Advisory Committee
568:Center for Drug Evaluation and Research
453:Section 361 of the same act allows the
348:Center for Drug Evaluation and Research
264:Renamed Division of Biologics Standards
250:Renamed Laboratory of Biologics Control
890:
888:
886:
884:
882:
880:
878:
876:
874:
872:
483:Vaccine Adverse Event Reporting System
477:Vaccine Adverse Event Reporting System
692:Risk Communication Advisory Committee
671:Patient Engagement Advisory Committee
306:) is one of six main centers for the
7:
2540:Regulators of biotechnology products
1127:Federal Food, Drug, and Cosmetic Act
536:and focused on vaccines, serums for
2457:Eradication of infectious diseases
2214:Androvax (androstenedione albumin)
937:"Committees and Meeting Materials"
668:Oncologic Drugs Advisory Committee
314:. The current Director of CBER is
257:National Microbiological Institute
25:
2545:Vaccination-related organizations
2047:Respiratory syncytial virus (RSV)
1087:Office of Criminal Investigations
997:100 Years of Biologics Regulation
772:(Job posting). FDA. 28 March 2018
308:U.S. Food and Drug Administration
2535:Vaccination in the United States
2436:Alternative vaccination schedule
1411:Artificial induction of immunity
1100:
962:
844:"in Google provided HTML format"
2575:Research institutes in Maryland
435:and in various sections of the
2268:Ovandrotone albumin (Fecundin)
1369:Commissioner of Food and Drugs
1151:Title 21 regulations and rules
1137:Prescription Drug User Fee Act
1077:Center for Veterinary Medicine
999:Centennial anniversary reports
803:"Keeping the public healthy".
549:Center for Drugs and Biologics
322:and related products (such as
310:(FDA), which is a part of the
1:
1804:Group B streptococcal disease
1623:Vaccines for Children Program
1132:Food Safety Modernization Act
527:National Institutes of Health
273:; renamed Bureau of Biologics
2530:Food and Drug Administration
1034:Food and Drug Administration
902:Bioresearch Monitoring Alert
674:Pediatric Advisory Committee
623:Arthritis Advisory Committee
576:tissue plasminogen activator
562:In 1987, under Commissioner
238:National Institute of Health
1072:Center for Tobacco Products
437:Food, Drug and Cosmetic Act
395:Diagnostic and therapeutic
226:Renamed Hygienic Laboratory
2591:
2550:National Influenza Centres
793:Retrieved August 30, 2012.
517:CBER's history began with
29:
2475:
1364:
1346:FDA Most Wanted Fugitives
1122:Modernization Act of 1997
1098:
505:Review and approval times
433:Public Health Service Act
289:
46:
39:
1799:Clostridioides difficile
791:CBER website, About CBER
545:biotechnology revolution
326:, live biotherapeutics (
2057:Tick-borne encephalitis
605:before their approval.
366:derivatives, including
2560:Life sciences industry
2467:List of vaccine topics
1467:Mathematical modelling
1142:Pure Food and Drug Act
540:, and blood products.
402:Live biotherapeutics (
2462:Vaccinate Your Family
1913:Japanese encephalitis
1300:Andrew von Eschenbach
1175:Federal Register (FR)
850:on September 1, 2009.
523:Biologics Control Act
344:Monoclonal antibodies
219:Laboratory of Hygiene
32:CBER (disambiguation)
2345:John Franklin Enders
1255:Alexander M. Schmidt
1531:Virus-like particle
1455:Vaccine ingredients
1334:Society and culture
1270:Arthur H. Hayes Jr.
1230:Charles W. Crawford
904:Sept. 2002. page 4.
589:Advisory committees
534:Bureau of Biologics
444:interstate commerce
417:Xenotransplantation
397:allergenic extracts
269:Transferred to the
27:FDA research center
18:Bureau of Biologics
2502:Never to phase III
2301:Hexavalent vaccine
2115:Epstein–Barr virus
2010:Oxford–AstraZeneca
1703:NmVac4-A/C/Y/W-135
1250:Charles C. Edwards
1220:Walter G. Campbell
1158:Administrative law
972:has a profile for
823:origin.www.fda.gov
609:Current committees
392:for use in humans.
255:Incorporated into
2512:
2511:
2424:Vaccines and SIDS
2311:
2310:
2085:Hepatitis A and B
2061:Varicella zoster
1523:Subunit/component
1377:
1376:
1235:George P. Larrick
1215:Charles A. Browne
1193:
1192:
978:
712:Former committees
603:COVID-19 vaccines
599:COVID-19 pandemic
519:a horse named Jim
501:virus selection.
499:influenza vaccine
296:
295:
211:2010 —
201:2000 —
191:1990 —
181:1980 —
171:1970 —
161:1960 —
151:1950 —
141:1940 —
131:1930 —
121:1920 —
111:1910 —
101:1900 —
91:1890 —
81:1880 —
41:CBER's past names
16:(Redirected from
2582:
2403:MMR autism fraud
2350:Maurice Hilleman
2335:Hilary Koprowski
1648:
1404:
1397:
1390:
1381:
1305:Margaret Hamburg
1280:David A. Kessler
1240:James L. Goddard
1155:
1104:
1103:
1027:
1020:
1013:
1004:
993:
992:
990:Official website
976:
966:
965:
949:
948:
946:
944:
933:
927:
926:
924:
922:
911:
905:
898:
867:
866:
858:
852:
851:
846:. Archived from
840:
834:
833:
831:
825:. Archived from
815:
809:
808:
800:
794:
788:
782:
781:
779:
777:
762:
756:
753:
481:As of 2003, the
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56:
50:
37:
21:
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2585:
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2581:
2580:
2579:
2515:
2514:
2513:
2508:
2507:
2492:Clinical trials
2471:
2440:
2379:
2355:Stanley Plotkin
2317:
2307:
2219:Cancer vaccines
2202:
2196:Schistosomiasis
2174:
2168:Trypanosomiasis
2141:
2105:Cytomegalovirus
2015:Pfizer–BioNTech
1815:
1639:
1588:Vaccine wastage
1558:
1486:
1438:
1408:
1378:
1373:
1360:
1329:
1295:Lester Crawford
1210:Carl L. Alsberg
1205:Harvey W. Wiley
1189:
1177:
1170:Federal journal
1165:
1146:
1105:
1101:
1096:
1040:
1031:
988:
987:
984:
983:
982:
967:
963:
958:
953:
952:
942:
940:
935:
934:
930:
920:
918:
913:
912:
908:
899:
870:
860:
859:
855:
842:
841:
837:
829:
817:
816:
812:
807:. October 2003.
802:
801:
797:
789:
785:
775:
773:
764:
763:
759:
754:
750:
745:
733:
714:
611:
591:
566:, CBER and the
515:
507:
495:
479:
455:Surgeon General
429:
368:immunoglobulins
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2370:Katalin KarikĂł
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2125:Herpes simplex
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2032:
2027:
2025:Sinopharm BIBP
2022:
2017:
2012:
2007:
2002:
1997:
1992:
1987:
1982:
1977:
1975:Bharat Biotech
1972:
1962:
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2296:DTwP-HepB-Hib
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2452:Epidemiology
2428:
2400:
2286:DTaP-IPV/Hib
2077:Yellow fever
1990:EpiVacCorona
1747:Tuberculosis
1720:Pneumococcal
1688:Lyme disease
1516:Heterologous
1415:Immunization
1320:Stephen Hahn
1051:
974:
941:. Retrieved
931:
919:. Retrieved
909:
901:
862:
856:
848:the original
838:
827:the original
822:
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786:
774:. Retrieved
769:
760:
751:
596:
592:
583:
580:
561:
553:Arthur Hayes
548:
542:
533:
531:
516:
508:
496:
493:Flu vaccines
480:
471:
460:
452:
441:
430:
336:cell, tissue
303:
299:
297:
2488:from market
2384:Controversy
2318:researchers
2234:Hepatitis B
2120:Hepatitis C
2065:Chicken pox
1891:Hepatitis E
1886:Hepatitis B
1881:Hepatitis A
1832:Chikungunya
1809:Shigellosis
1663:Brucellosis
1549:Therapeutic
1503:Inactivated
1443:Development
1431:Inoculation
1423:Vaccination
1182:Federal law
943:20 December
921:20 December
597:During the
564:Frank Young
487:Informatica
467:transfusion
372:hyperimmune
316:Peter Marks
49:This box:
2519:Categories
2419:Thiomersal
2365:Paul Offit
2340:Jonas Salk
2316:Inventors/
2187:research:
2164:research:
2101:research:
2030:Skycovione
2020:Sanofi–GSK
1965:SARS-CoV-2
1876:Hantavirus
1842:rVSV-ZEBOV
1827:Adenovirus
1795:research:
1673:Diphtheria
1511:Attenuated
1110:Major acts
977:(Q5059524)
743:References
404:probiotics
376:antitoxins
328:probiotics
2498:Phase III
2486:Withdrawn
2414:Pox party
2224:ALVAC-CEA
2146:Protozoan
2035:Sputnik V
1985:CoronaVac
1955:Rotavirus
1858:Pandemrix
1710:Pertussis
1651:Bacterial
1535:Synthetic
1498:Conjugate
1450:Adjuvants
1427:Infection
1045:Divisions
427:Authority
320:biologics
2256:Prostvac
2249:Gardasil
2244:Cervarix
2191:Hookworm
2070:Shingles
2052:Smallpox
1970:Corbevax
1906:Gardasil
1901:Cervarix
1644:Vaccines
1598:Schedule
1569:Global:
1477:Timeline
1419:Vaccines
805:KM World
776:28 March
731:See also
390:Vaccines
350:(CDER).
324:vaccines
236:Renamed
2445:Related
2391:General
2153:Malaria
2040:Valneva
2005:Novavax
2000:Moderna
1995:Janssen
1980:CanSino
1960:Rubella
1918:Measles
1789:Td/Tdap
1759:Typhoid
1742:Tetanus
1737:Q fever
1668:Cholera
1658:Anthrax
1527:Peptide
1491:Classes
1472:Storage
1036:of the
970:Scholia
641:(DODAC)
513:History
446:in the
221:founded
206:–
196:–
186:–
176:–
166:–
156:–
146:–
136:–
126:–
116:–
106:–
96:–
86:–
2481:WHO-EM
2401:Lancet
2278:TA-NIC
2263:NicVAX
2110:Dengue
1950:Rabies
1776:Typhus
1715:Plague
1593:Policy
1554:Toxoid
1482:Trials
364:plasma
338:, and
334:, and
2409:NCVIA
2273:TA-CD
2207:Other
2158:RTS,S
1938:Sabin
1933:Polio
1928:Mumps
1837:Ebola
1820:Viral
1769:ViCPS
1764:Ty21a
1698:MeNZB
1628:VAERS
1578:NITAG
1507:Live
830:(DOC)
422:CBER.
360:Blood
354:Scope
259:(NIH)
240:(NIH)
2135:Zika
2095:MMRV
1943:Salk
1923:Mpox
1869:LAIV
1864:H5N1
1854:H1N1
1730:PPSV
1613:ACIP
1609:US:
1583:SAGE
1544:mRNA
1460:list
945:2020
923:2020
778:2018
340:gene
304:CBER
298:The
69:edit
62:talk
55:view
2396:MMR
2239:HPV
2229:BCG
2130:HIV
2090:MMR
1896:HPV
1849:Flu
1752:BCG
1725:PCV
1678:Hib
1633:VSD
1540:DNA
1435:J07
572:HIV
411:HIV
330:),
271:FDA
2521::
2494::
1542:/
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1529:/
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399:.
302:(
34:.
20:)
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