Access to Investigational Drugs: FDA Expanded Access Programs or "Right-to-Try" Legislation?

Clinical and Translational Science

Volumn 8, Issue 5, 2015, Pages 526-532

  Holbein, M E Blair ^a   Berglund, Jelena P ^b   Weatherwax, Kevin ^c   Gerber, David E ^a   Adamo, Joan E ^d  

^a UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

^b DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF MICHIGAN HEALTH SYSTEM   (United States)

^d UNIVERSITY OF ROCHESTER MEDICAL CENTER   (United States)

Author keywords

FDA; New agents; Phase I; Trials

Indexed keywords

ARTICLE; DRUG APPROVAL; DRUG CONTROL; DRUG INDUSTRY; DRUG LEGISLATION; DRUG PROGRAM; DRUG SAFETY; HEALTH CARE ACCESS; HUMAN; INSTITUTIONAL REVIEW; PATIENT IDENTIFICATION; PATIENT SELECTION; POPULATION SIZE; PRIORITY JOURNAL; COMPASSIONATE USE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE DELIVERY; HEALTH CARE POLICY; LEGISLATION AND JURISPRUDENCE; ORGANIZATION AND MANAGEMENT; PATIENT SAFETY; PROGRAM DEVELOPMENT; RISK ASSESSMENT; RISK FACTOR; UNITED STATES;

NEW DRUG;

COMPASSIONATE USE TRIALS; DRUG APPROVAL; DRUGS, INVESTIGATIONAL; ELIGIBILITY DETERMINATION; HEALTH POLICY; HEALTH SERVICES ACCESSIBILITY; HUMANS; PATIENT SAFETY; PROGRAM DEVELOPMENT; RISK ASSESSMENT; RISK FACTORS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84946488699     PISSN: 17528054     EISSN: 17528062     Source Type: Journal    
DOI: 10.1111/cts.12255     Document Type: Article

References (24)

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