US FDA and personalized medicine: In vitro diagnostic regulatory perspective

Personalized Medicine

Volumn 7, Issue 5, 2010, Pages 517-530

  Težak, Živana ^a   Kondratovich, Marina V ^a   Mansfield, Elizabeth ^a  

^a CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

Author keywords

companion diagnostics; device regulation; FDA; invitro diagnostics; laboratory tests; personalized medicine; predictive markers; prognostic markers; regulatory challenges

Indexed keywords

BIOLOGICAL MARKER; EPIDERMAL GROWTH FACTOR RECEPTOR 2; TRASTUZUMAB;

DIAGNOSTIC KIT; FOOD AND DRUG ADMINISTRATION; HEALTH CARE PERSONNEL; HEALTH CARE POLICY; IN VITRO STUDY; LAW; MEDICINE; PRIORITY JOURNAL; PROGNOSIS; REVIEW; RISK ASSESSMENT;

EID: 77957556487     PISSN: 17410541     EISSN: 1744828X     Source Type: Journal    
DOI: 10.2217/pme.10.53     Document Type: Review

References (22)

1. US FDA: Federal Food, Drug and Cosmetic Act. Section §201 (h); 21 U. S. C. §321 (h). • Provides statutory definition of a medical device.
2. US FDA: Code of Federal Regulations Title 21 §809.3. • • Provides a definition of in vitro diagnostic product (IVD), defined by regulation.
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4. US FDA: Federal Food, Drug and Cosmetic Act. Section §513 (a); 21 U. S. C. §360c (a).
5. Tezak 2, Mansfield EA: FDA Regulation of Genetic Testing. In: In Vitro Diagnostics: The Complete Regulatory Guide. Danzis SD, Flannery EJ (Eds). Food and Drug Law Institute, Washington, DC, USA, 129-147 (2010). • Provides a good overview of IVD regulatory framework with emphasis on genetic testing.
6. US FDA: Code of Federal Regulations Title 21 §812.
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8. US FDA: Code of Federal Regulations Title 21 § 860.7 (e) (1).
9. US FDA: Code of Federal Regulations Title 21 § 809.10.
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