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Items: 1 to 20 of 137

1.

Successful investigational new drug preparation without reinventing the wheel.

Gorell ES, Tichy AL, Lane AT.

J Invest Dermatol. 2011 May;131(5):996-8. doi: 10.1038/jid.2011.38. No abstract available.

2.

Experimental drugs on trial.

Benderly BL.

Sci Am. 2007 Oct;297(4):92-9. No abstract available.

PMID:
17926760
3.

FDA treads delicate line between safety and speed.

[No authors listed]

Oncology (Williston Park). 1999 Jan;13(1):16. Review. No abstract available.

4.

Regulatory watch: FDA guidance on co-developing investigational drugs.

[No authors listed]

Nat Rev Drug Discov. 2011 Feb;10(2):86. doi: 10.1038/nrd3363. No abstract available.

PMID:
21283094
5.

New FDA breakthrough-drug category--implications for patients.

Darrow JJ, Avorn J, Kesselheim AS.

N Engl J Med. 2014 Mar 27;370(13):1252-8. doi: 10.1056/NEJMhle1311493. No abstract available. Erratum in: N Engl J Med. 2014 Jul 3;371(1):94.

6.

[From molecule to medicine--drug development].

Bruhn C.

Dtsch Med Wochenschr. 2010 Feb;135(6):p5. doi: 10.1055/s-0030-1247669. Epub 2010 Feb 11. German. No abstract available.

PMID:
20151355
7.

Faster is not always better.

Liebman M.

Clin J Oncol Nurs. 1998 Jan;2(1):3. No abstract available. Erratum in: Clin J Oncol Nurs 1998 Apr;2(2):42.

PMID:
9481249
8.

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. doi: 10.1038/nrd4651. Epub 2015 May 22. No abstract available.

PMID:
26000722
9.

Food and drug administration expanded access to treatment: implications for oncology patients.

Freedman RS, Markman M.

Cancer. 2007 Jun 1;109(11):2157-60. No abstract available.

10.

Balancing US patent and FDA approval processes: strategically optimizing market exclusivity.

Fernandez DS, Huie JT.

Drug Discov Today. 2004 Jun 15;9(12):509-12. No abstract available.

PMID:
15183155
11.

Drug development in serious diseases: the new "breakthrough therapy" designation.

Woodcock J.

Clin Pharmacol Ther. 2014 May;95(5):483-5. doi: 10.1038/clpt.2014.23.

PMID:
24747238
12.

New FDA breakthrough-drug category--implications for patients.

Ricart AD.

N Engl J Med. 2014 Jul 3;371(1):89. doi: 10.1056/NEJMc1405337#SA4. No abstract available.

PMID:
24988580
13.

New FDA breakthrough-drug category--implications for patients.

Velleca M.

N Engl J Med. 2014 Jul 3;371(1):88-9. doi: 10.1056/NEJMc1405337#SA3. No abstract available.

PMID:
24988579
14.

New FDA breakthrough-drug category--implications for patients.

Murray BE.

N Engl J Med. 2014 Jul 3;371(1):88. doi: 10.1056/NEJMc1405337#SA2. No abstract available.

PMID:
24988578
15.

New FDA breakthrough-drug category--implications for patients.

McClellan M, Sigal E.

N Engl J Med. 2014 Jul 3;371(1):87-8. doi: 10.1056/NEJMc1405337#SA1. No abstract available.

PMID:
24988577
16.

New FDA breakthrough-drug category--implications for patients.

Darrow JJ, Avorn J, Kesselheim AS.

N Engl J Med. 2014 Jul 3;371(1):89-90. doi: 10.1056/NEJMc1405337. No abstract available.

17.

Clinical development success rates for investigational drugs.

Hay M, Thomas DW, Craighead JL, Economides C, Rosenthal J.

Nat Biotechnol. 2014 Jan;32(1):40-51. doi: 10.1038/nbt.2786. No abstract available.

PMID:
24406927
18.

Legislative reform proposals.

Bruderle TP.

Am J Health Syst Pharm. 1996 Sep 1;53(17):2083-7. No abstract available.

PMID:
8870897
19.
20.

They are from the government and they really are here to help you.

Woosley RL.

J Clin Pharmacol. 2008 Feb;48(2):142-3. doi: 10.1177/0091270007313559. No abstract available.

PMID:
18199889

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