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Items: 1 to 20 of 163

1.

FDA review vouchers.

Moe J, Grabowski H, Ridley D.

N Engl J Med. 2009 Feb 19;360(8):837; author reply 837-8. doi: 10.1056/NEJMc086492. No abstract available.

2.

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.

3.

Developing drugs for developing countries.

Ridley DB, Grabowski HG, Moe JL.

Health Aff (Millwood). 2006 Mar-Apr;25(2):313-24.

4.

FDA and drug safety: new Tufts study challenges critics of the Prescription Drug User Fee Act.

Lee R.

J Law Med Ethics. 2006 Spring;34(1):131-4. No abstract available.

PMID:
16489994
5.

Drug safety reform at the FDA--pendulum swing or systematic improvement?

McClellan M.

N Engl J Med. 2007 Apr 26;356(17):1700-2. Epub 2007 Apr 13. No abstract available.

6.

A precarious balancing act--the role of the FDA as protector of public health and industry wealth.

McCabe AR.

Suffolk Univ Law Rev. 2003;36(3):787-819. No abstract available.

PMID:
16493844
7.

FDA launches priority vouchers for neglected-disease drugs.

Waltz E.

Nat Biotechnol. 2008 Dec;26(12):1315-6. doi: 10.1038/nbt1208-1315. No abstract available.

PMID:
19060849
8.

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
9.

Vouchers for FDA priority reviews.

Spatz ID.

Health Aff (Millwood). 2006 Jul-Aug;25(4):1184; author reply 1184-5. No abstract available.

10.

User fees to hasten FDA review.

Gershon D.

Nature. 1992 Oct 15;359(6396):567. No abstract available.

PMID:
1406982
11.

The economics of priority review vouchers.

Dimitri N.

Drug Discov Today. 2010 Nov;15(21-22):887-91. doi: 10.1016/j.drudis.2010.08.008. Epub 2010 Aug 21.

PMID:
20732445
12.

Industry funding of the FDA: effects of PDUFA on approval times and withdrawal rates.

Berndt ER, Gottschalk AH, Philipson TJ, Strobeck MW.

Nat Rev Drug Discov. 2005 Jul;4(7):545-54.

PMID:
16052239
13.

Tempered enthusiasm. Drug-safety law needs more teeth, patient-safety advocates say.

DerGurahian J.

Mod Healthc. 2007 Oct 8;37(40):16. No abstract available.

PMID:
18018373
14.

The Prescription Drug User Fee Act of 1992: speeding up the drug approval process.

Bierut MB.

Healthspan. 1992 Dec;9(11):12-4. No abstract available.

PMID:
10123552
15.

Letter from the Commissioner's Office at the US FDA.

Vernon JA.

Pharmacoeconomics. 2007;25(4):267-8. No abstract available.

PMID:
17402801
16.

Paying for drug approvals--who's using whom?

Avorn J.

N Engl J Med. 2007 Apr 26;356(17):1697-700. Epub 2007 Apr 13. No abstract available.

17.

What ails the FDA?

Okie S.

N Engl J Med. 2005 Mar 17;352(11):1063-6. No abstract available. Erratum in: N Engl J Med. 2005 Jun 16;352 (24):2563.

PMID:
15784660
18.

FDA joins market.

Gershon D.

Nature. 1993 Jul 8;364(6433):93. No abstract available.

PMID:
8321293
20.

New drug law to speed scientific review.

[No authors listed]

Nature. 1992 Oct 15;359(6396):563.

PMID:
1406977
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