The FDA breakthrough-drug designation - Four years of experience

New England Journal of Medicine

Volumn 378, Issue 15, 2018, Pages 1444-1453

  Darrow, Jonathan J ^a   Avorn, Jerry ^a   Kesselheim, Aaron S ^a  

^a HARVARD MEDICAL SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

IVACAFTOR; ORPHAN DRUG; PIMAVANSERIN; URIDINE TRIACETATE; ANTIINFECTIVE AGENT; NEW DRUG;

ARTICLE; DRUG APPROVAL; DRUG CONTROL; DRUG DESIGNATION; DRUG EFFICACY; DRUG LEGISLATION; DRUG SAFETY; DRUG SCREENING; EXPERIMENTAL THERAPY; FOOD AND DRUG ADMINISTRATION; HEALTH CARE ACCESS; PRIORITY JOURNAL; RISK BENEFIT ANALYSIS; TERMINAL DISEASE; CLINICAL TRIAL (TOPIC); DRUG DEVELOPMENT; DRUG INDUSTRY; HUMAN; LEGISLATION AND JURISPRUDENCE; NEOPLASM; PROCEDURES; RARE DISEASE; STATISTICS AND NUMERICAL DATA; UNITED STATES;

ANTI-INFECTIVE AGENTS; CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; DRUG DISCOVERY; DRUG INDUSTRY; DRUGS, INVESTIGATIONAL; HUMANS; INVESTIGATIONAL NEW DRUG APPLICATION; NEOPLASMS; RARE DISEASES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 85045514061     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMhpr1713338     Document Type: Article

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