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Items: 1 to 20 of 120

1.

Breakthrough drug category demands more communication.

Carroll J.

Manag Care. 2013 Aug;22(8):17-8. No abstract available.

2.

Development of novel combination therapies.

Woodcock J, Griffin JP, Behrman RE.

N Engl J Med. 2011 Mar 17;364(11):985-7. doi: 10.1056/NEJMp1101548. Epub 2011 Feb 16. No abstract available.

3.

Improving the FDA's advisory committee process.

Brass EP, Hiatt WR.

J Clin Pharmacol. 2012 Aug;52(8):1277-83. doi: 10.1177/0091270011412962. Epub 2011 Sep 10. No abstract available.

PMID:
21908879
4.

Drug development for neglected diseases - the trouble with FDA review vouchers.

Kesselheim AS.

N Engl J Med. 2008 Nov 6;359(19):1981-3. doi: 10.1056/NEJMp0806684. No abstract available.

5.

Target small firms for antibiotic innovation.

Hwang TJ, Carpenter D, Kesselheim AS.

Science. 2014 May 30;344(6187):967-9. doi: 10.1126/science.1251419. No abstract available.

PMID:
24876477
6.

The 21st Century Cures Act--Will It Take Us Back in Time?

Avorn J, Kesselheim AS.

N Engl J Med. 2015 Jun 25;372(26):2473-5. doi: 10.1056/NEJMp1506964. Epub 2015 Jun 3. No abstract available.

7.

FDA and EMEA pool scientific advice.

Katsnelson A.

Nat Biotechnol. 2004 Dec;22(12):1490-1. No abstract available.

PMID:
15583642
8.

FDA not NIH can speed new drugs.

Miller HI.

Nature. 2011 Apr 14;472(7342):169. doi: 10.1038/472169a. No abstract available.

PMID:
21490657
9.

Oncology's first Phase 0 trial.

Rowan K.

J Natl Cancer Inst. 2009 Jul 15;101(14):978-9. doi: 10.1093/jnci/djp213. Epub 2009 Jul 7. No abstract available.

10.

Regulatory watch: Innovation in biologic new molecular entities: 1986-2014.

Miller KL, Lanthier M.

Nat Rev Drug Discov. 2015 Feb;14(2):83. doi: 10.1038/nrd4535. No abstract available.

PMID:
25633785
11.

Accelerating identification and regulatory approval of investigational cancer drugs.

Esserman LJ, Woodcock J.

JAMA. 2011 Dec 21;306(23):2608-9. doi: 10.1001/jama.2011.1837. No abstract available.

PMID:
22187281
12.

Accelerated approval seen as triumph and roadblock for cancer drugs.

Susman E.

J Natl Cancer Inst. 2004 Oct 20;96(20):1495-6. No abstract available.

13.

Eyes on new product development.

Novack GD.

J Ocul Pharmacol Ther. 2013 Jul-Aug;29(6):513-4. doi: 10.1089/jop.2013.1508. No abstract available.

PMID:
23841863
14.

Muddied messages about FDA.

Miller HI.

Nat Biotechnol. 2003 Jul;21(7):732-3. No abstract available.

PMID:
12833084
15.

Fix the antibiotics pipeline.

Cooper MA, Shlaes D.

Nature. 2011 Apr 7;472(7341):32. doi: 10.1038/472032a. No abstract available.

PMID:
21475175
16.

A turbulent year at the agency.

Ratner M.

Nat Biotechnol. 2006 Feb;24(2):145-51. No abstract available.

PMID:
16465153
17.

Europe offers example for approving biosimilars.

Carroll J.

Manag Care. 2013 Sep;22(9):4-5. No abstract available.

18.

The role of the U.S. Food and Drug Administration review process: clinical trial endpoints in oncology.

McKee AE, Farrell AT, Pazdur R, Woodcock J.

Oncologist. 2010;15 Suppl 1:13-8. doi: 10.1634/theoncologist.2010-S1-13.

19.

Risk versus risk: decision-making dilemmas of drug regulation in the United States and Germany.

Daemmrich A, Krucken G.

Sci Cult (Lond). 2000 Dec;9(4):505-34. No abstract available.

PMID:
15988846
20.

2013 FDA drug approvals.

Mullard A.

Nat Rev Drug Discov. 2014 Feb;13(2):85-9. doi: 10.1038/nrd4239. No abstract available.

PMID:
24481294
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