Seamless oncology-drug development

New England Journal of Medicine

Volumn 374, Issue 21, 2016, Pages 2001-2003

  Prowell, Tatiana M ^a,b   Theoret, Marc R ^a   Pazdur, Richard ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b JOHNS HOPKINS UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY; PEMBROLIZUMAB;

CLINICAL TRIAL (TOPIC); DRUG APPROVAL; DRUG DEVELOPMENT; FOOD AND DRUG ADMINISTRATION; HUMAN; NEOPLASMS; ORGANIZATION AND MANAGEMENT; STANDARDS; THERAPEUTIC RESEARCH; UNITED STATES;

ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC AGENTS; CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; DRUG DISCOVERY; HUMANS; NEOPLASMS; THERAPEUTIC HUMAN EXPERIMENTATION; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84971315370     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMp1603747     Document Type: Review

References (5)

1. American Association for Cancer Research. Accelerating Anticancer Agent Development and Validation Workshop, Bethesda, MD, May 6-8, 2015 (http://www.aacr.org/Meetings/Pages/MeetingDetail.aspx?EventItemID=64#.VwPLmOnsbGt).
2. 2015 Friends-Brookings Conference on Clinical Cancer Research, Washington, DC, November 17, 2015 (http://www.focr.org/events/2015-friends-brookings-conference-clinical-cancer-research).
3. Electronic Code of Federal Regulations (e-CFR), Title 21, Section 312.47. Washington, DC: Government Printing Office (http://www.ecfr.gov/cgi-bin/text-idx?SID=8eef990f93702d038cbd4bb7c32df143&mc=true&node=se21.5.312-147&rgn=div8).
4. Guidance for industry: expedited programs for serious conditions-drugs and biologics. Silver Spring, MD: Food and Drug Administration, May 2014 (http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf).
5. Session detail: American Association for Cancer Research annual meeting, New Orleans, April 16-20, 2016 (http://www.abstractsonline.com/plan/ViewSession.aspx?sKey=4b13301d-c6e8-45af-985d-993fa57123cc&mKey=%7b1D10D749-4B6A-4AB3-BCD4-F80FB1922267%7d).