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Volumn 27, Issue 2, 2004, Pages 105-114

The US and European Regulatory Systems: A Comparison

(1)  Redmond, Kathy a  

a NONE   (Italy)

Author keywords

Approval time; Cancer; Drug approval; EMEA; Fast tracking; FDA; Medicines; Regulation

Indexed keywords

ALEMTUZUMAB; ALITRETINOIN; ALPHA2B INTERFERON; ANTINEOPLASTIC AGENT; ARCITUMOMAB TC 99M; ARSENIC TRIOXIDE; BEXAROTENE; CALCITONIN; CAPECITABINE; CYTARABINE; DEPREOTIDE TC 99M; DOCETAXEL; DOXORUBICIN; IBANDRONIC ACID; IGOVAMAB; INDIMACIS 125; LEXIDRONAM SAMARIUM SM 153; MELANOMA ANTIBODY; PACLITAXEL; RASBURICASE; RECOMBINANT ALPHA2B INTERFERON; RECOMBINANT THYROTROPIN; RITUXIMAB; SALCATONIN; TASONERMIN; TECNEMAB K1; TEMOPORFIN; TEMOZOLOMIDE; THYROTROPIN; TOPOTECAN; TOREMIFENE; TRASTUZUMAB; TRISONEX; UNCLASSIFIED DRUG; UNINDEXED DRUG; VOTUMUMAB; ZOLEDRONIC ACID;

EID: 1642320280     PISSN: 01489917     EISSN: None     Source Type: Journal    
DOI: 10.1097/00004479-200404000-00005     Document Type: Review
Times cited : (17)

References (15)
  • 5
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    • (CPMP/495/96 rev 1). London: Author
    • European Medicines Evaluation Agency. (2001). Accelerated evaluation of products indicated for serious diseases (CPMP/495/96 rev 1). London: Author. Available from http://www.emea.eu.int/pdfs/human/regaffair/049596en.pdf
    • (2001) Accelerated Evaluation of Products Indicated for Serious Diseases
  • 7
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    • EMEA/CPMP/257/03/en final
    • European Medicines Evaluation Agency. (2003b). EMEA/CPMP Therapeutic Advisory Groups: Rules of procedure (EMEA/CPMP/257/03/en final). Available from http://www.emea.eu.int/pdfs/human/therapeutic/025703en.pdf
    • (2003) EMEA/CPMP Therapeutic Advisory Groups: Rules of Procedure
  • 8
    • 85039581941 scopus 로고    scopus 로고
    • EMEA/CPMP/2613/03
    • European Medicines Evaluation Agency. (2003c). EMEA/CPMP Working group with patients' organisations (EMEA/CPMP/2613/03). Available from http://www.emea.eu.int/pdfs/human/patientgroup/261303en.pdf
    • (2003) EMEA/CPMP Working Group with Patients' Organisations
  • 9
    • 1642338991 scopus 로고    scopus 로고
    • Rockville, MD: Center for Drug Evaluation and Research
    • Food and Drug Administration. (1996). Priority review policy. Rockville, MD: Center for Drug Evaluation and Research. Available from http://www.fda.gov/cder/mapp/6020-3.pdf
    • (1996) Priority Review Policy
  • 11
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    • Rockville, MD: Author
    • Food and Drug Administration. (1999). Cancer patient representative program. Rockville, MD: Author. Available from http://www.fda.gov/oashi/cancer/cpat.html
    • (1999) Cancer Patient Representative Program
  • 12
    • 85039576133 scopus 로고    scopus 로고
    • Rockville, MD: Author
    • Food and Drug Administration. (2001). Cancer drug development patient consultant program. Rockville, MD: Author. Available from http://www.fda.gov/oashi/cancer/pconback.html
    • (2001) Cancer Drug Development Patient Consultant Program
  • 13
    • 85039577094 scopus 로고    scopus 로고
    • Rockville, MD: Author
    • Food and Drug Administration. (2002). Investigational new drug application process. Rockville, MD: Author. Available from http://www.fda.gov/cder/regulatory/applications/ind_page_1.htm#Introduction
    • (2002) Investigational New Drug Application Process


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.