The 21st century cures act - Will it take us back in time?

New England Journal of Medicine

Volumn 372, Issue 26, 2015, Pages 2473-2475

  Avorn, Jerry ^a   Kesselheim, Aaron S ^a  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DEVICE APPROVAL; DRUG APPROVAL; DRUG EFFICACY; DRUG LABELING; DRUG LEGISLATION; DRUG SAFETY; DRUG USE; GOVERNMENT REGULATION; HEALTH CARE POLICY; HUMAN; PRIORITY JOURNAL; REVIEW; RISK BENEFIT ANALYSIS; DRUG DEVELOPMENT; ECONOMICS; FINANCIAL MANAGEMENT; FOOD AND DRUG ADMINISTRATION; LEGISLATION AND JURISPRUDENCE; NATIONAL HEALTH ORGANIZATION; UNITED STATES;

BIOLOGICAL MARKER;

BIOMARKERS; DEVICE APPROVAL; DRUG APPROVAL; DRUG DISCOVERY; GOVERNMENT REGULATION; HUMANS; NATIONAL INSTITUTES OF HEALTH (U.S.); RESEARCH SUPPORT AS TOPIC; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84932617711     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMp1506964     Document Type: Article

References (5)

1. 21st Century Cures Act. May 19, 2015 (http://docs.house.gov/meetings/IF/IF00/20150519/103516/BILLS-1146ih.pdf).
2. Kesselheim AS, Tan YT, Avorn J. The roles of academia, rare diseases, and repurposing in the development of the most transformative drugs. Health Aff (Millwood) 2015;34: 286-93.
3. Downing NS, Aminawung JA, Shah ND, Krumholz HM, Ross JS. Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012. JAMA 2014; 311:368-77.
4. Avorn J. Approval of a tuberculosis drug based on a paradoxical surrogate measure. JAMA 2013;309:1349-50.
5. Dhruva SS, Bero LA, Redberg RF. Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices. JAMA 2009;302:2679-85.