Introduction to the food and drug administration (FDA) regulatory process

Journal of Proteome Research

Volumn 4, Issue 4, 2005, Pages 1110-1113

  Hackett, Joseph L ^a   Gutman, Steven I ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Biomarkers; FDA; Genomics; In vitro diagnostic; Pre IDE; Proteomics

Indexed keywords

DEVICE; DIAGNOSTIC TEST; FOOD AND DRUG ADMINISTRATION; GENOMICS; GOOD MANUFACTURING PRACTICE; LABORATORY TEST; LAW; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PROTEOMICS; REVIEW; UNITED STATES;

ANIMALS; BIOLOGICAL MARKERS; DEVICE APPROVAL; HUMANS; LABORATORY TECHNIQUES AND PROCEDURES; MOLECULAR DIAGNOSTIC TECHNIQUES; PROTEOME; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 23944492885     PISSN: 15353893     EISSN: None     Source Type: Journal    
DOI: 10.1021/pr050059a     Document Type: Review

References (5)

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2. Bruns, D. E. The START initiative and the reporting of diagnostic accuracy. Clin. Chem. 2003, 49, 19-20.
3. Gutman, S.; Feigal, D. Decision making in pharmacogenomic diagnosis: is there anything new under the sun? Drug Discovery Today 2003, 8 (17), 765-766.
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5. The Critical Path to New Medical Products, White Paper, U.S. Department of Health and Human Services, Food and Drug Administration, March 2004. http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html.