The role of the U.S. Food and Drug Administration review process: clinical trial endpoints in oncology.

The oncologist

Volumn 15 Suppl 1, Issue , 2010, Pages 13-18

  McKee, Amy E ^a   Farrell, Ann T ^b   Pazdur, Richard ^b   Woodcock, Janet ^b  

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

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL TRIAL; DRUG APPROVAL; DRUG LEGISLATION; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HUMAN; LEGAL ASPECT; NEOPLASM; ORGANIZATION AND MANAGEMENT; POSTMARKETING SURVEILLANCE; SURVIVAL; TREATMENT OUTCOME; UNITED STATES;

CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; GOVERNMENT REGULATION; HUMANS; INVESTIGATIONAL NEW DRUG APPLICATION; LEGISLATION, DRUG; NEOPLASMS; PRODUCT SURVEILLANCE, POSTMARKETING; SURVIVAL ANALYSIS; TREATMENT OUTCOME; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 77954629858     PISSN: None     EISSN: 1549490X     Source Type: Journal    
DOI: 10.1634/theoncologist.2010-S1-13     Document Type: Article

References (0)