COST EFFECTIVENESS ANALYSIS;
DRUG APPROVAL;
DRUG EFFICACY;
DRUG LABELING;
DRUG MARKETING;
DRUG SAFETY;
DRUG TOLERABILITY;
FOOD AND DRUG ADMINISTRATION;
INFORMATION DISSEMINATION;
MEDICAL INFORMATICS;
NOTE;
OUTCOME ASSESSMENT;
PACKAGING;
PRESCRIPTION;
PRIORITY JOURNAL;
RISK BENEFIT ANALYSIS;
SOCIAL SECURITY;
ARTICLE;
COMPARATIVE EFFECTIVENESS;
ORGANIZATION AND MANAGEMENT;
RANDOMIZED CONTROLLED TRIAL;
SAFETY;
STANDARD;
UNITED STATES;
COMPARATIVE EFFECTIVENESS RESEARCH;
DEVICE APPROVAL;
DRUG APPROVAL;
PRODUCT LABELING;
RANDOMIZED CONTROLLED TRIALS AS TOPIC;
UNITED STATES;
UNITED STATES FOOD AND DRUG ADMINISTRATION;
Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices
Dhruva SS, Bero LA, Redberg RF. Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices. JAMA. 2009;302(24): 2679-2685.
Code of Federal Regulations. Title 21, part 314-Applications for FDA approval to market a new drug: subpart D-FDA action on applications and abbreviated applications. Section 314.125-Refusal to approve an application, February 2, 2010
Code of Federal Regulations. Title 21, part 314-Applications for FDA approval to market a new drug: subpart D-FDA action on applications and abbreviated applications. Section 314.125-Refusal to approve an application. http: //www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314 .125. Accessed February 2, 2010.
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Code of Federal Regulations. Title 21, part 860-Medical device classification procedures: subpart A-general. Section 860.7-Determination of safety and effectiveness, February 2, 2010
Code of Federal Regulations. Title 21, part 860-Medical device classification procedures: subpart A-general. Section 860.7-Determination of safety and effectiveness. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/ cfcfr/CFRSearch .cfm?fr=860.7. Accessed February 2, 2010.
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Industry influence on comparative-effectiveness research funded through health care reform
Selker HP, Wood AJJ. Industry influence on comparative-effectiveness research funded through health care reform. N Engl J Med. 2009;361(27):2595-2597.
(2009)N Engl J Med, vol.361, Issue.27, pp. 2595-2597
New, but not improved? incorporating comparative-effectiveness information into FDA labeling
Stafford RS, Wagner TH, Lavori PW. New, but not improved? incorporating comparative-effectiveness information into FDA labeling. N Engl J Med. 2009; 361(13):1230-1233.
(2009)N Engl J Med, vol.361, Issue.13, pp. 1230-1233
European Medicines Agency. EU standard of medicinal product registration: clinical evaluation of risk/benefit-the role of comparator studies. http://www .emea.europa.eu/pdfs/human/press/pos/11931904en.pdf. Posted October 2004. Accessed February 2, 2010.
European Medicines Agency. EU standard of medicinal product registration: clinical evaluation of risk/benefit-the role of comparator studies. http://www .emea.europa.eu/pdfs/human/press/pos/11931904en.pdf. Posted October 2004. Accessed February 2, 2010.
* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.