344 related articles for article (PubMed ID: 16832956)
21. The Food and Drug Administration's early access and fast-track approval initiatives: how have they worked?
Shulman SR; Brown JS
Food Drug Law J; 1995; 50(4):503-31. PubMed ID: 10343017
[No Abstract] [Full Text] [Related]
22. Food and Drug Administration responds to pressure for expanded drug access.
Brower V
J Natl Cancer Inst; 2014 Jun; 106(6):dju171. PubMed ID: 24907387
[No Abstract] [Full Text] [Related]
23. Should terminally ill patients have access to phase I drugs?
Bristol N
Lancet; 2007 Mar; 369(9564):815-6. PubMed ID: 17366691
[No Abstract] [Full Text] [Related]
24. Tricky FDA debate: should a risky drug be approved again?
Mathews AW; Westphal SP
Wall St J (East Ed); 2006 Feb; ():B1, B4. PubMed ID: 16528879
[No Abstract] [Full Text] [Related]
25. The FDA's drug review process: ensuring drugs are safe and effective.
Meadows M
FDA Consum; 2002; 36(4):19-24. PubMed ID: 12184298
[No Abstract] [Full Text] [Related]
26. 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]
27. "Right to Try" Laws: The Gap between Experts and Advocates.
Dresser R
Hastings Cent Rep; 2015; 45(3):9-10. PubMed ID: 25944200
[No Abstract] [Full Text] [Related]
28. Maine law requires drug companies to provide clinical trial data.
Appell D
J Natl Cancer Inst; 2005 Sep; 97(17):1246. PubMed ID: 16145043
[No Abstract] [Full Text] [Related]
29. Expanded clinical trials of treatments for multiple sclerosis: copolymer 1 (COP-1) treatment investigational new drug (IND) program.
Stark Y
Ann Neurol; 1994 Jul; 36(1):114-5. PubMed ID: 8024251
[No Abstract] [Full Text] [Related]
30. Respiratory controversies in the critical care setting. When caring for critically ill patients, do clinicians have a responsibility to be innovative and try unproven approaches when accepted approaches are failing?
Rubin BK; Steinberg KP
Respir Care; 2007 Apr; 52(4):408-15. PubMed ID: 17417975
[TBL] [Abstract][Full Text] [Related]
31. Executive summary from the final reports of the National Committee to Review Current Procedures for Approval of New Drugs for Cancer and AIDS.
Oncology (Williston Park); 1991 Apr; 5(4):16, 18-9. PubMed ID: 1831034
[No Abstract] [Full Text] [Related]
32. A critical tipping point.
Zuckerman MB
US News World Rep; 2002 Apr; 132(13):72. PubMed ID: 11993366
[No Abstract] [Full Text] [Related]
33. TransMolecular receives FDA approval for 131-I-TM-601 IND application.
Expert Rev Anticancer Ther; 2002 Apr; 2(2):139. PubMed ID: 12113233
[No Abstract] [Full Text] [Related]
34. Food and drug administration expanded access to treatment: implications for oncology patients.
Freedman RS; Markman M
Cancer; 2007 Jun; 109(11):2157-60. PubMed ID: 17450587
[No Abstract] [Full Text] [Related]
35. Access for the terminally ill to experimental medical innovations: a three-pronged threat.
Bender S; Flicker L; Rhodes R
Am J Bioeth; 2007 Oct; 7(10):3-6. PubMed ID: 17926208
[No Abstract] [Full Text] [Related]
36. Experimental drugs on trial.
Benderly BL
Sci Am; 2007 Oct; 297(4):92-9. PubMed ID: 17926760
[No Abstract] [Full Text] [Related]
37. Current good manufacturing practice and investigational new drugs intended for use in clinical trials. Final rule.
Food and Drug Administration, HHS
Fed Regist; 2008 Jul; 73(136):40453-63. PubMed ID: 18850678
[TBL] [Abstract][Full Text] [Related]
38. 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]
39. Second thoughts: do the FDA's responses to a fatal drug trial and the AIDS activist community's doubts about early access to drugs hint at a shift in basic FDA policy?
Lovell MC
Food Drug Law J; 1996; 51(2):273-94. PubMed ID: 11820202
[No Abstract] [Full Text] [Related]
40. Regulatory watch: Why do oncology drugs fail to gain US regulatory approval?
Khozin S; Liu K; Jarow JP; Pazdur R
Nat Rev Drug Discov; 2015 Jul; 14(7):450-1. PubMed ID: 26000722
[No Abstract] [Full Text] [Related]
[Previous] [Next] [New Search]
