Walking the drug regulatory tightrope

Nature Biotechnology

Volumn 21, Issue 5, 2003, Pages 495-498

  Dove, Alan ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; ALEFACEPT; ALEMTUZUMAB; BIOLOGICAL PRODUCT; BLOOD CLOTTING FACTOR 8; BOTULINUM TOXIN B; CHORIONIC GONADOTROPIN ALPHA SUBUNIT; CROTALIDAE POLYVALENT IMMUNOGLOBULIN FAB FRAGMENT; DEXFENFLURAMINE; DIBOFERMIN ALPHA; DIGOXIN ANTIBODY F(AB) FRAGMENT; DROTRECOGIN; FENFLURAMINE; FIBRIN GLUE; GEMTUZUMAB OZOGAMICIN; IBRITUMOMAB TIUXETAN; INSULIN ASPART; INSULIN GLARGINE; NESIRITIDE; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; OSTEOGENIC PROTEIN 1; PARATHYROID HORMONE[1-34]; PEGINTERFERON ALPHA2A; PEGINTERFERON ALPHA2B; PEGVISOMANT; RASBURICASE; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; RECOMBINANT INTERLEUKIN 1 RECEPTOR BLOCKING AGENT; TENECTEPLASE; UNCLASSIFIED DRUG; UNINDEXED DRUG;

BIOTECHNOLOGY; DRUG APPROVAL; DRUG INDUSTRY; DRUG LEGISLATION; DRUG MANUFACTURE; DRUG RESEARCH; FOOD AND DRUG ADMINISTRATION; HUMAN; ORGANIZATION; PRESCRIPTION; PRIORITY JOURNAL; REVIEW; UNITED STATES; VALVULAR HEART DISEASE;

EID: 0038333617     PISSN: 10870156     EISSN: None     Source Type: Journal    
DOI: 10.1038/nbt0503-495     Document Type: Review

References (7)

1. Bouchie, A. FDA restructures product review centers. Nat. Biotechnol. 20, 960 (2002).
2. Biotechnology Industry Organization CEO and Investor Conference, New York, NY, February 26-27, 2003.
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4. Dove, A. Promising drug is victim of bad business. Nat. Med. 8, 199 (2002).
5. Improving Innovation in Medical Technology: Beyond 2002 (FDA, Rockland, MD, 2002).
6. Walsh, G. Drug approval in Europe. Nat, Biotechnol. 17, 237-240 (1999).
7. Kaitin, K.I. (ed.). Biopharmaceutical product approval times dropped 21% since 1980s (Tufts Center for the Study of Drug Development Impact Report, 5(2), Mar/Apr, 2003).