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Volumn 1, Issue 3, 2008, Pages 188-189

The FDA regulatory process for drug and genetic diagnostic test approvals

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL RESEARCH; DIAGNOSTIC TEST; DRUG APPROVAL; FOOD AND DRUG ADMINISTRATION; GENETIC MARKER; GOVERNMENT REGULATION; HUMAN; PATENT; PATIENT SAFETY; PHARMACOGENETICS; PRIORITY JOURNAL; UNITED STATES;

EID: 77953445360     PISSN: 17528054     EISSN: 17528062     Source Type: Journal    
DOI: 10.1111/j.1752-8062.2008.00066.x     Document Type: Article
Times cited : (1)

References (11)
  • 2
    • 77953378627 scopus 로고    scopus 로고
    • Rights to inventions made by nonprofit organizations and small business firms under government grants, contracts, and cooperative agreements
    • 37 CFR 401. (Current through July 1, 2007). Text from: Code of Federal Regulations. Accessed October 15
    • 37 CFR 401. Rights to inventions made by nonprofit organizations and small business firms under government grants, contracts, and cooperative agreements. (Current through July 1, 2007). Text from: Code of Federal Regulations. Accessed October 15, 2008.
    • (2008)
  • 3
    • 77953448446 scopus 로고    scopus 로고
    • CDER. Accessed September 10
    • CDER. New drug evaluation process, http://www.fda.gov/cder/regulator/ applications/NDA.htm. Accessed September 10, 2008.
    • (2008) New Drug Evaluation Process
  • 5
    • 17144391455 scopus 로고    scopus 로고
    • The U.S. Food and Drug Administration Cardio-renal Advisory Panel and the drug approval process
    • Roden DM, Temple R. The U.S. Food and Drug Administration Cardio-renal Advisory Panel and the drug approval process. Circulation. 2005; 111: 1697-1702.
    • (2005) Circulation , vol.111 , pp. 1697-1702
    • Roden, D.M.1    Temple, R.2
  • 6
    • 77953383527 scopus 로고    scopus 로고
    • Draft guidance for the public and FDA staff on convening advisory committee meetings
    • U.S. FDA
    • U.S. FDA. Draft guidance for the public and FDA staff on convening advisory committee meetings. Fed Regist. 2008;73(151):45455-45456.
    • (2008) Fed Regist , vol.73 , Issue.15 , pp. 45455-45456
  • 7
    • 33846928249 scopus 로고    scopus 로고
    • BiDil for heart failure in black patients: The U.S. Food and Drug Administration perspective
    • Temple R, Stockbridge NL. BiDil for heart failure in black patients: The U.S. Food and Drug Administration perspective. Ann Int Med 2007;146:57-62.
    • (2007) Ann Int Med , vol.146 , pp. 57-62
    • Temple, R.1    Stockbridge, N.L.2
  • 9
    • 77953370665 scopus 로고    scopus 로고
    • FDA damned if it does, damned if it doesn't
    • November 9
    • Simons J. FDA damned if it does, damned if it doesn't. Fortune. November 9, 2007.
    • (2007) Fortune
    • Simons, J.1
  • 10
    • 77953450888 scopus 로고    scopus 로고
    • Drug makers say FDA is slowing new-medicine pipeline
    • June 30
    • Johnson A, Winslow R. Drug makers say FDA is slowing new-medicine pipeline. Wall Street Journal. June 30, 2008.
    • (2008) Wall Street Journal
    • Johnson, A.1    Winslow, R.2
  • 11
    • 77953461693 scopus 로고    scopus 로고
    • Leerink Swann/MedaCorp 2008 Regulatory Review, January 16
    • Leerink Swann/MedaCorp 2008 Regulatory Review, January 16, 2008.
    • (2008)


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.