These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.
319 related articles for article (PubMed ID: 22037027)
1. Accelerated approval dust begins to settle. Mullard A Nat Rev Drug Discov; 2011 Oct; 10(11):797-8. PubMed ID: 22037027 [No Abstract] [Full Text] [Related]
2. Effective global drug development strategy for obtaining regulatory approval in Japan in the context of ethnicity-related drug response factors. Ichimaru K; Toyoshima S; Uyama Y Clin Pharmacol Ther; 2010 Mar; 87(3):362-6. PubMed ID: 20107436 [No Abstract] [Full Text] [Related]
3. The special treatment. Osborne R Nat Biotechnol; 2008 May; 26(5):487-9. PubMed ID: 18464770 [No Abstract] [Full Text] [Related]
4. Accelerated approval of oncology products: the food and drug administration experience. Johnson JR; Ning YM; Farrell A; Justice R; Keegan P; Pazdur R J Natl Cancer Inst; 2011 Apr; 103(8):636-44. PubMed ID: 21422403 [TBL] [Abstract][Full Text] [Related]
5. Examining Manufacturing Readiness for Breakthrough Drug Development. Dye E; Sturgess A; Maheshwari G; May K; Ruegger C; Ramesh U; Tan H; Cockerill K; Groskoph J; Lacana E; Lee S; Miksinski SP AAPS PharmSciTech; 2016 Jun; 17(3):529-38. PubMed ID: 26608693 [No Abstract] [Full Text] [Related]
6. Hurry up and wait: is accelerated approval of new cancer drugs in the best interests of cancer patients? Schilsky RL J Clin Oncol; 2003 Oct; 21(20):3718-20. PubMed ID: 12963701 [No Abstract] [Full Text] [Related]
7. Accelerated approval of oncology drugs: can we do better? Ellenberg SS J Natl Cancer Inst; 2011 Apr; 103(8):616-7. PubMed ID: 21422401 [No Abstract] [Full Text] [Related]
8. Regulatory watch: FDA guidance on co-developing investigational drugs. Nat Rev Drug Discov; 2011 Feb; 10(2):86. PubMed ID: 21283094 [No Abstract] [Full Text] [Related]
9. Benefit the patient, manage the risk: a system goal. Califf RM Pharmacoepidemiol Drug Saf; 2004 May; 13(5):269-76. PubMed ID: 15133777 [No Abstract] [Full Text] [Related]
10. The ODAC Chronicles: Part 4. Hurdles pre and post accelerated approval. Grillo-López AJ Expert Rev Anticancer Ther; 2005 Apr; 5(2):197-200. PubMed ID: 15877516 [No Abstract] [Full Text] [Related]
11. Accelerated approval of oncology products: a decade of experience. Dagher R; Johnson J; Williams G; Keegan P; Pazdur R J Natl Cancer Inst; 2004 Oct; 96(20):1500-9. PubMed ID: 15494600 [TBL] [Abstract][Full Text] [Related]
12. Accelerated approval regulations may need overhaul, panel suggests. Finkelstein JB J Natl Cancer Inst; 2005 Dec; 97(24):1802-4. PubMed ID: 16368938 [No Abstract] [Full Text] [Related]
13. Oncology's first Phase 0 trial. Rowan K J Natl Cancer Inst; 2009 Jul; 101(14):978-9. PubMed ID: 19584322 [No Abstract] [Full Text] [Related]
14. The United States Food and Drug Administration and noninferiority margins in clinical trials of antimicrobial agents. Powers JH; Ross DB; Brittain E; Albrecht R; Goldberger MJ Clin Infect Dis; 2002 Mar; 34(6):879-81. PubMed ID: 11850875 [No Abstract] [Full Text] [Related]
15. Accelerated approval and oncology drug development timelines. Lanthier ML; Sridhara R; Johnson JR; Farrell A; Keegan P; Justice R; Pazdur R J Clin Oncol; 2010 May; 28(14):e226-7; author reply e228. PubMed ID: 20194846 [No Abstract] [Full Text] [Related]
16. Accelerating orphan drug development. Coté TR; Xu K; Pariser AR Nat Rev Drug Discov; 2010 Dec; 9(12):901-2. PubMed ID: 21119719 [TBL] [Abstract][Full Text] [Related]
17. Prospects for rapid advances in the development of new medicines for special medical needs. Milne CP Clin Pharmacol Ther; 2014 Jan; 95(1):98-109. PubMed ID: 23917473 [TBL] [Abstract][Full Text] [Related]
18. Errors in 'Trials and error'. Miller DD Nat Biotechnol; 2006 Jul; 24(7):747. PubMed ID: 16841048 [No Abstract] [Full Text] [Related]
19. There is no better time than the present: nanotechnology as a disruptive innovation for drug development. Oo C; Tsai JC; Kao HD Drug Discov Today; 2015 Jun; 20(6):645-7. PubMed ID: 25835226 [No Abstract] [Full Text] [Related]
20. Advancing Alzheimer's disease drug review as a national priority. Perry DP Alzheimers Dement; 2009 Mar; 5(2):180-1. PubMed ID: 19328455 [TBL] [Abstract][Full Text] [Related] [Next] [New Search]