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Volumn 40, Issue 5, 2013, Pages 439-441

Regulatory considerations for a traumatic brain injury (TBI) indication for hyperbaric oxygen (HBO2)

Author keywords

[No Author keywords available]

Indexed keywords

AIR QUALITY CONTROL; ARTICLE; BRAIN INJURY; DEVICE APPROVAL; EQUIPMENT; FINANCIAL MANAGEMENT; FOOD AND DRUG ADMINISTRATION; HUMAN; HYPERBARIC OXYGEN; LEGAL ASPECT; METHODOLOGY; STANDARD; UNITED STATES;

EID: 84884518796     PISSN: 10662936     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article
Times cited : (2)

References (8)
  • 3
    • 70349247863 scopus 로고    scopus 로고
    • Understanding FDA regulatory requirements for investigational new drug applications for sponsorinvestigators
    • Aug
    • Holbein ME. Understanding FDA regulatory requirements for investigational new drug applications for sponsorinvestigators. J Investig Med. 2009 Aug;57(6):688-94.
    • (2009) J Investig Med. , vol.57 , Issue.6 , pp. 688-694
    • Holbein, M.E.1
  • 4
    • 84884524201 scopus 로고    scopus 로고
    • U.S. Department of Health and Human Services Food and Drug Administration. "Off-label" and investigational use of marketed drugs, biologics, and medical devices - information sheet. Silver Spring, MD: Food and Drug Administration; August. Accessed March 6, 2013
    • U.S. Department of Health and Human Services Food and Drug Administration. Guidance for Institutional Review Boards and clinical investigators. "Off-label" and investigational use of marketed drugs, biologics, and medical devices - information sheet. Silver Spring, MD: Food and Drug Administration; August 2011. Available at: http://www.fda.gov/ RegulatoryInformation/Guidances/ucm126486.htm. Accessed March 6, 2013.
    • (2011) Guidance for Institutional Review Boards and Clinical Investigators
  • 6
    • 0003497355 scopus 로고    scopus 로고
    • U.S. Department of Health and Human Services Food and Drug Administration. Silver Spring, MD: Food and Drug Administration; April Accessed March 6, 2013
    • U.S. Department of Health and Human Services Food and Drug Administration. Guidance for industry. E6 Good Clinical Practice: consolidated guidance. Silver Spring, MD: Food and Drug Administration; April 1996. Available at: http://www.fda.gov/downloads/Drugs/GuidanceCompliance- RegulatoryInformation/Guidances/UCM073122.pdf. Accessed March 6, 2013.
    • (1996) Guidance for Industry. E6 Good Clinical Practice: Consolidated Guidance
  • 7
    • 84865288637 scopus 로고    scopus 로고
    • Hyperbaric oxygen for post-concussion syndrome: Design of Department of Defense clinical trials
    • Jul-Aug
    • Weaver LK, Cifu D, Hart B, Wolf G, Miller S. Hyperbaric oxygen for post-concussion syndrome: design of Department of Defense clinical trials. Undersea Hyperb Med. 2012 Jul-Aug;39(4):807-14.
    • (2012) Undersea Hyperb Med. , vol.39 , Issue.4 , pp. 807-814
    • Weaver, L.K.1    Cifu, D.2    Hart, B.3    Wolf, G.4    Miller, S.5
  • 8
    • 79959283469 scopus 로고    scopus 로고
    • U.S. Department of Health and Human Services Food and Drug Administration. Silver Spring, MD: Food and Drug Administration; December Accessed March 6, 2013
    • U.S. Department of Health and Human Services Food and Drug Administration. Guidance for industry and investigators. Safety reporting requirements for INDs and BA/BE studies. Silver Spring, MD: Food and Drug Administration; December 2012. Available at: http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM227351.pdf. Accessed March 6, 2013.
    • (2012) Guidance for Industry and Investigators. Safety Reporting Requirements for INDs and BA/BE Studies


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.