Would a breakthrough therapy by any other name be as promising?

JAMA Internal Medicine

Volumn 175, Issue 11, 2015, Pages 1858-1859

  Ross, Joseph S ^a   Redberg, Rita F ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL PRODUCT; ANTINEOPLASTIC AGENT;

BREAKTHROUGH THERAPY; CANCER CHEMOTHERAPY; DRUG DEVELOPMENT; DRUG EFFICACY; DRUG MANUFACTURE; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HUMAN; LETTER; LUNG CANCER; MEDICAL DEVICE; PRESCRIPTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); DRUG APPROVAL; FEMALE; LUNG NEOPLASMS; MALE; PROCEDURES; STANDARDS;

ANTINEOPLASTIC AGENTS; DRUG APPROVAL; FEMALE; HUMANS; LUNG NEOPLASMS; MALE;

EID: 84946138528     PISSN: 21686106     EISSN: 21686114     Source Type: Journal    
DOI: 10.1001/jamainternmed.2015.5311     Document Type: Letter

References (6)

1. US Food and Drug Administration Safety and Innovation Act of 2012. Public Law No: 112-144. https://www.congress.gov/bill/112th-congress/senate-bill/3187. Accessed August 18, 2015.
2. Downing NS, Aminawung JA, Shah ND, Braunstein JB, Krumholz HM, Ross JS. Regulatory review of novel therapeutics: comparison of three regulatory agencies. N Engl J Med. 2012;366(24):2284-2293.
3. Krishnamurti T, Woloshin S, Schwartz LM, Fischhoff B. A randomized trial testing US Food and Drug Administration "breakthrough" language [published online September 21, 2015]. JAMA Intern Med. doi:10.1001/jamainternmed.2015 .5355.
4. US Food and Drug Administration. Frequently asked questions: breakthrough therapies. http://www.fda.gov/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/FDASIA/ucm341027.htm. Accessed August 3, 2015.
5. Prasad V, Kim C, Burotto M, Vandross A. The strength of association between surrogate end points and survival in oncology: a systematic review of trial-level meta-analyses. JAMA Intern Med. 2015;175(8):1389-1398.
6. 21st Century Cures Act. HR 6. http://docs.house.gov/billsthisweek/20150706/CPRT-114-HPRT-RU00-HR6.pdf. Accessed August 18, 2015.