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Results: 1 to 20 of 96

1.

Nothing to do and all day to do it in.

Petsko GA.

Genome Biol. 2011 Aug 31;12(8):126. doi: 10.1186/gb-2011-12-8-126. No abstract available.

PMID:
21884638
[PubMed - indexed for MEDLINE]
Free PMC Article
2.

Orphan products: an emerging trend in drug approvals.

Coté T, Kelkar A, Xu K, Braun MM, Phillips MI.

Nat Rev Drug Discov. 2010 Jan;9(1):84. doi: 10.1038/nrd2546-c1. No abstract available.

PMID:
20043031
[PubMed - indexed for MEDLINE]
3.

Nonclinical development of radiopharmaceuticals: regulatory considerations for the United States Food and Drug Administration.

Wilson S.

Ernst Schering Res Found Workshop. 2004;(48):151-65. Review. No abstract available.

PMID:
15248521
[PubMed - indexed for MEDLINE]
4.

Promoting, improving and accelerating the drug development and approval processes.

Graul AI.

Drug News Perspect. 2009 Jan-Feb;22(1):30-8. doi: 10.1358/dnp.2009.22.1.1303816.

PMID:
19209297
[PubMed - indexed for MEDLINE]
5.

Will politics sidetrack FDA reform?

Gatty B.

Formulary. 1995 Aug;30(8):476, 475. No abstract available.

PMID:
10151736
[PubMed - indexed for MEDLINE]
6.

The decreased number of new drug approvals (NDAs) has been a topic of considerable debate over the past decade. Preface.

Enna SJ, Williams M.

Adv Pharmacol. 2009;57:xi-ii. doi: 10.1016/S1054-3589(08)57015-3. No abstract available.

PMID:
19945649
[PubMed - indexed for MEDLINE]
7.

Old drugs, new uses: solving a Hatch-Waxman patent predicament.

McPhie DC.

Food Drug Law J. 2004;59(1):155-68. No abstract available.

PMID:
15190929
[PubMed - indexed for MEDLINE]
8.

The process of drug development.

Burgess G.

Surviv News (Atlanta Ga). 2002 Mar:18. No abstract available.

PMID:
11966191
[PubMed - indexed for MEDLINE]
9.

It's good to talk.

[No authors listed]

Nat Rev Drug Discov. 2006 Mar;5(3):173. No abstract available.

PMID:
16557652
[PubMed - indexed for MEDLINE]
10.

Clinical investigators as critical determinants in pharmaceutical innovation.

Flowers CR, Melmon KL.

Nat Med. 1997 Feb;3(2):136-43. Review. No abstract available.

PMID:
9018224
[PubMed - indexed for MEDLINE]
11.

Merck v. Integra: Supreme Court permits use of patented compounds to obtain Food and Drug Administration approvals.

Manthei JR, Hathaway CR, Grant MA, Chung DD.

Food Drug Law J. 2006;61(2):273-7. No abstract available.

PMID:
16903032
[PubMed - indexed for MEDLINE]
12.

Good drug, bad luck: business, regulatory issues can create obstacles for drug development.

Goldman B.

J Natl Cancer Inst. 2004 Nov 3;96(21):1573-4. No abstract available.

PMID:
15523084
[PubMed - indexed for MEDLINE]
Free Article
13.

Where have all the antibiotic patents gone?

Katz ML, Mueller LV, Polyakov M, Weinstock SF.

Nat Biotechnol. 2006 Dec;24(12):1529-31.

PMID:
17160057
[PubMed - indexed for MEDLINE]
14.

Food and Drug Administration, partner in drug development.

Yates JW.

CA Cancer J Clin. 2006 Nov-Dec;56(6):321-2. No abstract available.

PMID:
17135690
[PubMed - indexed for MEDLINE]
15.

Hatch-Waxman in the Federal Courts: from 1994--2004.

Ludwig SP, Kosinski KB, Harris J.

Drug Dev Ind Pharm. 2005 Jan;31(2):215-22. Review.

PMID:
15773288
[PubMed - indexed for MEDLINE]
16.

Barriers to efficient development of cancer therapeutics.

Schein PS, Scheffler B.

Clin Cancer Res. 2006 Jun 1;12(11 Pt 1):3243-8. Review. No abstract available.

PMID:
16740743
[PubMed - indexed for MEDLINE]
Free Article
17.

Experimental use and the Orphan Drug Act: a biotechnology conundrum.

Koivuniemi PJ.

Nat Biotechnol. 1996 Apr;14(4):511-2. No abstract available.

PMID:
9630930
[PubMed - indexed for MEDLINE]
18.

HHS ruling on Plan B introduces new risk for drugmakers.

Willyard C.

Nat Med. 2012 Jan 6;18(1):8. doi: 10.1038/nm0112-8a. No abstract available.

PMID:
22227652
[PubMed - indexed for MEDLINE]
19.

[Orphan drugs: drugs for rare diseases].

Schenk M.

Dtsch Med Wochenschr. 2010 May;135(18):p17. German. No abstract available.

PMID:
20455291
[PubMed - indexed for MEDLINE]
20.

FDA reform: new Senate bill. Food and Drug Administration.

James JS.

AIDS Treat News. 1995 Nov 17;(no 235):7-8.

PMID:
11363048
[PubMed - indexed for MEDLINE]

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