FDA introductory comments: Clinical studies design and evaluation issues

Clinical Trials

Volumn 2, Issue 4, 2005, Pages 273-275

  Woodcock, Janet ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBIOTIC AGENT;

ANTIBIOTIC RESISTANCE; BAYES THEOREM; CLINICAL STUDY; CLINICAL TRIAL; CONFERENCE PAPER; CONSENSUS; DECISION MAKING; DRUG APPROVAL; DRUG DESIGN; DRUG INDUSTRY; DRUG MARKETING; FOOD AND DRUG ADMINISTRATION; HUMAN; PNEUMONIA; PRIORITY JOURNAL; SINUSITIS; SUBSTITUTION THERAPY; URINARY TRACT INFECTION;

BAYES THEOREM; CLINICAL TRIALS; DRUG APPROVAL; DRUG EVALUATION; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 24944527868     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1191/1740774505cn096oa     Document Type: Conference Paper

References (2)

1. Food and Drug Administration. Innovation or stagnation? challenge and opportunity on the critical path to new medical products, Retrieved March 2004, from: http:// www.fda.gov/oc/initiatives/criticalpath/whitepaper.html
2. Food and Drug Administration. Providing clinical evidence of effectiveness for human drug and biological products, guidance for industry, Retrieved 20 July 2005, from: http://www.fda.gov/cder/guidance/index.htm