Regulatory and scientific issues regarding use of foreign data in support of new drug applications in the United States: An FDA perspective

Clinical Pharmacology and Therapeutics

Volumn 94, Issue 2, 2013, Pages 230-242

  Khin, N A ^a   Yang, P ^b   Hung, H M J ^b   Maung U, K ^a   Chen, Y F ^b   Meeker O'Connell, A ^b   Okwesili, P ^b   Yasuda, S U ^a   Ball, L K ^b   Huang, S M ^b   O'Neill, R T ^b   Temple, R ^a,b  

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

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

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; BEDAQUILINE; BREAST CANCER RESISTANCE PROTEIN; CARBAMAZEPINE; CLOPIDOGREL; CYTOCHROME P450 2D6; DRUG METABOLIZING ENZYME; EPTIFIBATIDE; HYDRALAZINE PLUS ISOSORBIDE DINITRATE; INTRINSIC FACTOR; LOW DENSITY LIPOPROTEIN CHOLESTEROL; METOPROLOL SUCCINATE; NEW DRUG; NICOTINIC ACID; PLACEBO; ROSUVASTATIN; SIMVASTATIN; STREPTOKINASE; TACROLIMUS; TICAGRELOR; WARFARIN;

ACUTE CORONARY SYNDROME; ADVERSE OUTCOME; AFRICAN AMERICAN; ANTERIOR MYOCARDIAL INFARCTION; BODY COMPOSITION; BODY HEIGHT; BODY MASS; BODY WEIGHT; CARDIOVASCULAR MORTALITY; CAUCASIAN; CEREBROVASCULAR ACCIDENT; CHINESE; CONGESTIVE HEART FAILURE; DRUG APPROVAL; DRUG SAFETY; EASTERN EUROPE; ETHNIC DIFFERENCE; FOOD AND DRUG ADMINISTRATION; GENE FREQUENCY; GENETIC DIFFERENCE; GENETIC POLYMORPHISM; GENETIC VARIABILITY; GOOD CLINICAL PRACTICE; HAMILTON SCALE; HEART MUSCLE REVASCULARIZATION; HOSPITAL ADMISSION; HOSPITAL CARE; HOSPITALIZATION; HUMAN; HYPERCHOLESTEROLEMIA; HYPERTENSION; JAPANESE; LEAN BODY WEIGHT; MAINTENANCE DRUG DOSE; MAJOR DEPRESSION; MEDICAL PRACTICE; META ANALYSIS; MULTICENTER STUDY (TOPIC); MULTIDRUG RESISTANT TUBERCULOSIS; MUSCLE INJURY; NEW YORK HEART ASSOCIATION CLASS; NORTH AMERICA; OUTCOME ASSESSMENT; PERCUTANEOUS CORONARY INTERVENTION; PLACEBO EFFECT; POSITIVE AND NEGATIVE SYNDROME SCALE; PRIORITY JOURNAL; PROTOCOL COMPLIANCE; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECOMMENDED DRUG DOSE; REVIEW; RISK REDUCTION; SAMPLE SIZE; SINGLE NUCLEOTIDE POLYMORPHISM; SOCIAL STATUS; SOUTH AND CENTRAL AMERICA; ST SEGMENT ELEVATION; STENT THROMBOSIS; STEVENS JOHNSON SYNDROME; UNITED STATES; UNIVERSITY HOSPITAL; UNSTABLE ANGINA PECTORIS; WELLBEING; WESTERN EUROPE;

ANTIPSYCHOTIC AGENTS; CARDIOVASCULAR AGENTS; CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; GUIDELINES AS TOPIC; HUMANS; INTERNATIONALITY; ORPHAN DRUG PRODUCTION; PHARMACOLOGY, CLINICAL; RESEARCH DESIGN; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84880728271     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2013.70     Document Type: Review

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