Timing and Characteristics of Cumulative Evidence Available on Novel Therapeutic Agents Receiving Food and Drug Administration Accelerated Approval

Milbank Quarterly

Volumn 95, Issue 2, 2017, Pages 261-290

  Naci, Huseyin ^a   Wouters, Olivier J ^a   Gupta, Radhika ^b   Ioannidis, John P A ^c  

^a LONDON SCHOOL OF ECONOMICS   (United Kingdom)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

^c STANFORD UNIVERSITY   (United States)

Author keywords

accelerated approval; Food and Drug Administration; market authorization; pharmaceutical policy

Indexed keywords

ALEMTUZUMAB; BEDAQUILINE; BORTEZOMIB; CARFILZOMIB; CETUXIMAB; CLOFARABINE; CRIZOTINIB; DARUNAVIR; DEFERASIROX; DEFERIPRONE; ELTROMBOPAG; ENFUVIRTIDE; ETRAVIRINE; GEFITINIB; GEMTUZUMAB; IBRITUMOMAB TIUXETAN; IBRUTINIB; IMATINIB; LENALIDOMIDE; LOPINAVIR; MARAVIROC; NATALIZUMAB; NELARABINE; NILOTINIB; OFATUMUMAB; RALTEGRAVIR; TENOFOVIR; TIPRANAVIR; TREPROSTINIL; UNINDEXED DRUG;

ARTICLE; DRUG APPROVAL; DRUG INDICATION; FABRY DISEASE; FOOD AND DRUG ADMINISTRATION; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IDIOPATHIC THROMBOCYTOPENIC PURPURA; IRON OVERLOAD; MALIGNANT NEOPLASM; MULTIPLE SCLEROSIS; PRIORITY JOURNAL; PULMONARY HYPERTENSION; RANDOMIZED CONTROLLED TRIAL (TOPIC); TUBERCULOSIS; DRUG CONTROL; EVIDENCE BASED MEDICINE; META ANALYSIS (TOPIC); ORGANIZATION AND MANAGEMENT; TIME FACTOR; UNITED STATES;

DRUG AND NARCOTIC CONTROL; DRUG APPROVAL; EVIDENCE-BASED MEDICINE; META-ANALYSIS AS TOPIC; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TIME FACTORS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 85020287336     PISSN: 0887378X     EISSN: 14680009     Source Type: Journal    
DOI: 10.1111/1468-0009.12261     Document Type: Article

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