-
2
-
-
59449088862
-
Antibiotic-resistant bugs in the 21st century - A clinical super-challenge
-
Arias CA, Murray BE. Antibiotic-resistant bugs in the 21st century - a clinical super-challenge. N Engl J Med 2009;360:439-43.
-
(2009)
N Engl J Med
, vol.360
, pp. 439-443
-
-
Arias, C.A.1
Murray, B.E.2
-
3
-
-
0037157590
-
Drug development for neglected diseases: A deficient market and a public-health policy failure
-
DOI 10.1016/S0140-6736(02)09096-7
-
Trouiller P, Olliaro P, Torreele E, Orbinski J, Laing R, Ford N. Drug development for neglected diseases: a deficient market and a public-health policy failure. Lancet 2002;359:2188-94. (Pubitemid 34694030)
-
(2002)
Lancet
, vol.359
, Issue.9324
, pp. 2188-2194
-
-
Trouiller, P.1
Olliaro, P.2
Torreele, E.3
Orbinski, J.4
Laing, R.5
Ford, N.6
-
4
-
-
46749083039
-
Pathways across the valley of death: Novel intellectual property strategies for accelerated drug discovery
-
Rai AK, Reichman JH, Uhlir PF, Crossman C. Pathways across the valley of death: novel intellectual property strategies for accelerated drug discovery. Yale J Health Policy Law Ethics 2008;8:1-36.
-
(2008)
Yale J Health Policy Law Ethics
, vol.8
, pp. 1-36
-
-
Rai, A.K.1
Reichman, J.H.2
Uhlir, P.F.3
Crossman, C.4
-
5
-
-
33745956680
-
Industry sweats after patent verdict
-
Frantz S. Industry sweats after patent verdict. Nat Rev Drug Discov 2006;5:443-4.
-
(2006)
Nat Rev Drug Discov
, vol.5
, pp. 443-444
-
-
Frantz, S.1
-
7
-
-
70350128141
-
Balancing innovation and access: Patent challenges tip the scales
-
Higgins MJ, Graham SJH. Balancing innovation and access: patent challenges tip the scales. Science 2009;326:370-1.
-
(2009)
Science
, vol.326
, pp. 370-371
-
-
Higgins, M.J.1
Graham, S.J.H.2
-
8
-
-
64149099072
-
Unpatentable drugs and the standards of patentability
-
Roin BN. Unpatentable drugs and the standards of patentability. Tex Law Rev 2009;87:503-70.
-
(2009)
Tex Law Rev
, vol.87
, pp. 503-570
-
-
Roin, B.N.1
-
9
-
-
57349151132
-
Drug development for neglected diseases - The trouble with FDA review vouchers
-
Kesselheim AS. Drug development for neglected diseases - the trouble with FDA review vouchers. N Engl J Med 2008; 359:1981-3.
-
(2008)
N Engl J Med
, vol.359
, pp. 1981-1983
-
-
Kesselheim, A.S.1
-
10
-
-
33645680700
-
Developing drugs for developing countries
-
Millwood
-
Ridley DB, Grabowski HG, Moe JL. Developing drugs for developing countries. Health Aff (Millwood) 2006;25:313-24.
-
(2006)
Health Aff
, vol.25
, pp. 313-324
-
-
Ridley, D.B.1
Grabowski, H.G.2
Moe, J.L.3
-
11
-
-
77149173500
-
Market exclusivity for biologics
-
Wheadon DE. Market exclusivity for biologics. N Engl J Med 2010;362:661.
-
(2010)
N Engl J Med
, vol.362
, pp. 661
-
-
Wheadon, D.E.1
-
12
-
-
77958040408
-
State generic substitution laws can lower drug outlays under Medicaid
-
Millwood
-
Shrank WH, Choudhry NK, Agnew-Blais J, et al. State generic substitution laws can lower drug outlays under Medicaid. Health Aff (Millwood) 2010;29:1383-90.
-
(2010)
Health Aff
, vol.29
, pp. 1383-1390
-
-
Shrank, W.H.1
Choudhry, N.K.2
Agnew-Blais, J.3
-
13
-
-
32644435800
-
The implications of choice: Prescribing generic or preferred pharmaceuticals improves medication adherence for chronic conditions
-
DOI 10.1001/archinte.166.3.332
-
Shrank WH, Hoang T, Ettner SL, et al. The implications of choice: prescribing generic or preferred pharmaceuticals improves medication adherence for chronic conditions. Arch Intern Med 2006;166:332-7. (Pubitemid 43244321)
-
(2006)
Archives of Internal Medicine
, vol.166
, Issue.3
, pp. 332-337
-
-
Shrank, W.H.1
Hoang, T.2
Ettner, S.L.3
Glassman, P.A.4
Nair, K.5
DeLapp, D.6
Dirstine, J.7
Avorn, J.8
Asch, S.M.9
-
14
-
-
78650483446
-
With expanded coverage for the poor, fears of a big headache
-
April 27
-
Rabin RC. With expanded coverage for the poor, fears of a big headache. New York Times. April 27, 2010.
-
(2010)
New York Times
-
-
Rabin, R.C.1
-
15
-
-
0035941514
-
Adverse events associated with prescription drug cost-sharing among poor and elderly persons
-
Tamblyn R, Laprise R, Hanley JA, et al. Adverse events associated with prescription drug cost-sharing among poor and elderly persons. JAMA 2001;285:421-9.
-
(2001)
JAMA
, vol.285
, pp. 421-429
-
-
Tamblyn, R.1
Laprise, R.2
Hanley, J.A.3
-
16
-
-
85031251717
-
-
Act of Dec. 12, 1980, Pub. L. No. 96-517, 94 Stat. 3015-3028 (codified as amended at 35 U.S.C. 200-211, 301-307 (1994))
-
Act of Dec. 12, 1980, Pub. L. No. 96-517, 94 Stat. 3015-3028 (codified as amended at 35 U.S.C. 200-211, 301-307 (1994)).
-
-
-
-
18
-
-
0346720525
-
Public research and private development: Patents and technology transfer in government-sponsored research
-
Eisenberg RS. Public research and private development: patents and technology transfer in government-sponsored research. VA Law Rev 1996;82:1663-727.
-
(1996)
VA Law Rev
, vol.82
, pp. 1663-1727
-
-
Eisenberg, R.S.1
-
19
-
-
0013311853
-
Numbers, quality, and entry: How has the Bayh-Dole Act affected U.S. patenting and licensing?
-
Jaffe AB, Lerner J, Stern S, eds. Cambridge, MA: MIT Press
-
Mowery DC, Ziedonis AA. Numbers, quality, and entry: how has the Bayh-Dole Act affected U.S. patenting and licensing? In: Jaffe AB, Lerner J, Stern S, eds. Innovation policy and the economy. Vol. 1. Cambridge, MA: MIT Press, 2001:187-220.
-
(2001)
Innovation Policy and the Economy
, vol.1
, pp. 187-220
-
-
Mowery, D.C.1
Ziedonis, A.A.2
-
20
-
-
0032373981
-
Universities as a source of commercial technology: A detailed analysis of university patenting: 1965-1988
-
Henderson R, Jaffe AB, Trajtenberg M. Universities as a source of commercial technology: a detailed analysis of university patenting: 1965-1988. Rev Econ Stat 2001;80:119-27.
-
(2001)
Rev Econ Stat
, vol.80
, pp. 119-127
-
-
Henderson, R.1
Jaffe, A.B.2
Trajtenberg, M.3
-
21
-
-
0039332029
-
-
Washington, DC: April GAO publication no. RCED-87-44
-
Patent policy: recent changes in federal law considered beneficial. Washington, DC: General Accounting Office, April 1987. (GAO publication no. RCED-87-44.) (http://archive.gao.gov/ t2pbat21/132994.pdf.)
-
(1987)
Patent Policy: Recent Changes in Federal Law Considered Beneficial
-
-
-
22
-
-
0001139237
-
Proofs and prototypes for sale: The licensing of University inventions
-
Jensen R, Thursby M. Proofs and prototypes for sale: the licensing of university inventions. Am Econ Rev 2001;91:240-59. (Pubitemid 33594479)
-
(2001)
American Economic Review
, vol.91
, Issue.1
, pp. 240-259
-
-
Jensen, R.1
Thursby, M.2
-
23
-
-
30544437182
-
The licensing of DNA patents by US academic institutions: An empirical survey
-
DOI 10.1038/nbt0106-31, PII NBT010631
-
Pressman L, Burgess R, Cook-Deegan RM, et al. The licensing of DNA patents by US academic institutions: an empirical survey. Nat Biotechnol 2006;24:31-9. (Pubitemid 43083162)
-
(2006)
Nature Biotechnology
, vol.24
, Issue.1
, pp. 31-39
-
-
Pressman, L.1
Burgess, R.2
Cook-Deegan, R.M.3
McCormack, S.J.4
Nami-Wolk, I.5
Soucy, M.6
Walters, L.7
-
24
-
-
6944245130
-
-
Stanford, CA: Stanford Business Books
-
Mowery DC, Nelson RR, Sampat BN, Ziedonis AA. Ivory tower and industrial innovation: university-industry technology transfer before and after the Bayh-Dole Act. Stanford, CA: Stanford Business Books, 2004.
-
(2004)
Ivory Tower and Industrial Innovation: University-industry Technology Transfer before and after the Bayh-Dole Act
-
-
Mowery, D.C.1
Nelson, R.R.2
Sampat, B.N.3
Ziedonis, A.A.4
-
25
-
-
0346657500
-
The growth of patenting and licensing by U.S. universities: An assessment of the effects of the Bayh-Dole Act of 1980
-
Idem.
-
Idem. The growth of patenting and licensing by U.S. universities: an assessment of the effects of the Bayh-Dole Act of 1980. Res Policy 2001;30:99-119.
-
(2001)
Res Policy
, vol.30
, pp. 99-119
-
-
Mowery, D.C.1
Nelson, R.R.2
Sampat, B.N.3
Ziedonis, A.A.4
-
26
-
-
0141681123
-
Changes in university patent quality after the Bayh-Dole Act: A re-examination
-
Sampat BN, Mowery DC, Ziedonis AA. Changes in university patent quality after the Bayh-Dole Act: a re-examination. Int J Ind Organ 2003;21:1371-90.
-
(2003)
Int J Ind Organ
, vol.21
, pp. 1371-1390
-
-
Sampat, B.N.1
Mowery, D.C.2
Ziedonis, A.A.3
-
27
-
-
29544447648
-
Technology licensing: Lessons from the US experience
-
Sobolski GK, Barton JH, Emanuel EJ. Technology licensing: lessons from the US experience. JAMA 2005;294:3137-40.
-
(2005)
JAMA
, vol.294
, pp. 3137-3140
-
-
Sobolski, G.K.1
Barton, J.H.2
Emanuel, E.J.3
-
28
-
-
57949108752
-
U.S. universities' net returns from patenting and licensing: A quantile regression analysis
-
Bulut H, Moschini G. U.S. universities' net returns from patenting and licensing: a quantile regression analysis. Econ Innovation New Technol 2009;18:123-37.
-
(2009)
Econ Innovation New Technol
, vol.18
, pp. 123-137
-
-
Bulut, H.1
Moschini, G.2
-
29
-
-
0032076909
-
Can patents deter innovation? The anticommons in biomedical research
-
Heller MA, Eisenberg RS. Can patents deter innovation? The anticommons in biomedical research. Science 1998;280:698-701.
-
(1998)
Science
, vol.280
, pp. 698-701
-
-
Heller, M.A.1
Eisenberg, R.S.2
-
30
-
-
0037160567
-
Data with-holding in academic genetics: Evidence from a national survey
-
Campbell EG, Clarridge BR, Gokhale M, et al. Data with-holding in academic genetics: evidence from a national survey. JAMA 2002;287:473-81.
-
(2002)
JAMA
, vol.287
, pp. 473-481
-
-
Campbell, E.G.1
Clarridge, B.R.2
Gokhale, M.3
-
31
-
-
0030903440
-
Withholding research results in academic life science: Evidence from a national survey of faculty
-
Blumenthal D, Campbell EG, Anderson MS, Causino N, Louis KS. Withholding research results in academic life science: evidence from a national survey of faculty. JAMA 1997; 277:1224-8.
-
(1997)
JAMA
, vol.277
, pp. 1224-1228
-
-
Blumenthal, D.1
Campbell, E.G.2
Anderson, M.S.3
Causino, N.4
Louis, K.S.5
-
32
-
-
25444510682
-
View from the bench: Patents and material transfers
-
DOI 10.1126/science.1115813
-
Walsh JP, Cho C, Cohen WM. View from the bench: patents and material transfers. Science 2005;309:2002-3. (Pubitemid 41362303)
-
(2005)
Science
, vol.309
, Issue.5743
, pp. 2002-2003
-
-
Walsh, J.P.1
Cho, C.2
Cohen, W.M.3
-
33
-
-
0037436166
-
Working through the patient problem
-
Walsh JP, Cohen WH, Arora A. Working through the patient problem. Science 2003;299:1021.
-
(2003)
Science
, vol.299
, pp. 1021
-
-
Walsh, J.P.1
Cohen, W.H.2
Arora, A.3
-
34
-
-
13844253332
-
University-based science and biotechnology products: Defining the boundaries of intellectual property
-
DOI 10.1001/jama.293.7.850
-
Kesselheim AS, Avorn J. University-based science and biotechnology products: defining the boundaries of intellectual property. JAMA 2005;293:850-4. (Pubitemid 40250369)
-
(2005)
Journal of the American Medical Association
, vol.293
, Issue.7
, pp. 850-854
-
-
Kesselheim, A.S.1
Avorn, J.2
-
35
-
-
54949130185
-
Is Bayh-Dole good for developing countries? Lessons from the US experience
-
So AD, Sampat BN, Rai AK, et al. Is Bayh-Dole good for developing countries? Lessons from the US experience. PLoS Biol 2008;6(10):e262.
-
(2008)
PLoS Biol
, vol.6
, Issue.10
-
-
So, A.D.1
Sampat, B.N.2
Rai, A.K.3
-
36
-
-
85031268974
-
-
21 U.S.C. 360bb(a)(2) (2008)
-
21 U.S.C. 360bb(a)(2) (2008).
-
-
-
-
37
-
-
0004245789
-
-
Rockville, MD: Department of Health and Human Services, February
-
Report of the National Commission on Orphan Diseases. Rockville, MD: Department of Health and Human Services, February 1989.
-
(1989)
Report of the National Commission on Orphan Diseases
-
-
-
38
-
-
32044463568
-
Adopting orphan drugs - Two dozen years of treating rare diseases
-
Haffner ME. Adopting orphan drugs - two dozen years of treating rare diseases. N Engl J Med 2006;354:445-7.
-
(2006)
N Engl J Med
, vol.354
, pp. 445-447
-
-
Haffner, M.E.1
-
39
-
-
57649109461
-
Clinical research for rare disease: Opportunities, challenges, and solutions
-
Griggs RC, Batshaw M, Dunkle M, et al. Clinical research for rare disease: opportunities, challenges, and solutions. Mol Genet Metab 2009;96:20-6.
-
(2009)
Mol Genet Metab
, vol.96
, pp. 20-26
-
-
Griggs, R.C.1
Batshaw, M.2
Dunkle, M.3
-
40
-
-
34147140020
-
Creation and development of the public service orphan drug Human Botulism Immune Globulin
-
Arnon SS. Creation and development of the public service orphan drug Human Botulism Immune Globulin. Pediatrics 2007;119:785-9.
-
(2007)
Pediatrics
, vol.119
, pp. 785-789
-
-
Arnon, S.S.1
-
41
-
-
0026464728
-
Creating the costliest orphan: The Orphan Drug Act in the development of Ceredase
-
Goldman DP, Clarke AE, Garber AM. Creating the costliest orphan: the Orphan Drug Act in the development of Ceredase. Int J Technol Assess Health Care 1992;8:583-97.
-
(1992)
Int J Technol Assess Health Care
, vol.8
, pp. 583-597
-
-
Goldman, D.P.1
Clarke, A.E.2
Garber, A.M.3
-
42
-
-
0028788896
-
The economics of orphan drug policy in the US: Can the legislation be improved?
-
Peabody JW, Ruby A, Cannon P. The economics of orphan drug policy in the US: can the legislation be improved? Pharmacoeconomics 1995;8:374-84.
-
(1995)
Pharmacoeconomics
, vol.8
, pp. 374-384
-
-
Peabody, J.W.1
Ruby, A.2
Cannon, P.3
-
44
-
-
70349880348
-
R&D policy, agency costs and innovation in personalized medicine
-
Yin W. R&D policy, agency costs and innovation in personalized medicine. J Health Econ 2009;28:950-62.
-
(2009)
J Health Econ
, vol.28
, pp. 950-962
-
-
Yin, W.1
-
45
-
-
0029183838
-
Rare diseases, drug development, and AIDS: The impact of the Orphan Drug Act
-
Arno PS, Bonuck K, Davis M. Rare diseases, drug development, and AIDS: the impact of the Orphan Drug Act. Milbank Q 1995;73:231-52.
-
(1995)
Milbank Q
, vol.73
, pp. 231-252
-
-
Arno, P.S.1
Bonuck, K.2
Davis, M.3
-
46
-
-
57149085867
-
Prioritizing future research on off-label prescribing: Results of a quantitative evaluation
-
Walton SM, Schumock GT, Lee KV, Alexander GC, Meltzer D, Stafford RS. Prioritizing future research on off-label prescribing: results of a quantitative evaluation. Pharmacotherapy 2008;28:1443-52.
-
(2008)
Pharmacotherapy
, vol.28
, pp. 1443-1452
-
-
Walton, S.M.1
Schumock, G.T.2
Lee, K.V.3
Alexander, G.C.4
Meltzer, D.5
Stafford, R.S.6
-
47
-
-
33750983605
-
Correction of anemia with epoetin alfa in chronic kidney disease
-
DOI 10.1056/NEJMoa065485
-
Singh AK, Szczech L, Tang KL, et al. Correction of anemia with epoetin alfa in chronic kidney disease. N Engl J Med 2006; 355:2085-98. (Pubitemid 44749317)
-
(2006)
New England Journal of Medicine
, vol.355
, Issue.20
, pp. 2085-2098
-
-
Singh, A.K.1
Szczech, L.2
Tang, K.L.3
Barnhart, H.4
Sapp, S.5
Wolfson, M.6
Reddan, D.7
-
48
-
-
85031268156
-
-
Pub. L. No. 98-417, 98 Stat. 1585 (1984)
-
Pub. L. No. 98-417, 98 Stat. 1585 (1984).
-
-
-
-
50
-
-
0141604347
-
Special patent provisions for pharmaceuticals: Have they outlived their usefulness?
-
Engelberg AL. Special patent provisions for pharmaceuticals: have they outlived their usefulness? IDEA J Law Technol 1999;39:389-426.
-
(1999)
IDEA J Law Technol
, vol.39
, pp. 389-426
-
-
Engelberg, A.L.1
-
51
-
-
0029838687
-
Longer patents for increased generic competition in the US: The Waxman-Hatch Act after one decade
-
Grabowski HG, Vernon JM. Longer patents for increased generic competition in the US: the Waxman-Hatch Act after one decade. Pharmacoeconomics 1996;10:Suppl 2:110-23.
-
(1996)
Pharmacoeconomics
, vol.10
, Issue.SUPPL. 2
, pp. 110-123
-
-
Grabowski, H.G.1
Vernon, J.M.2
-
53
-
-
66249084667
-
Drug patent life and generic entry: Analysis of the new molecular entities approved by the FDA between 1980 and 1999
-
Seoane-Vazquez E, Schondelmeyer S, Szeinbach SL. Drug patent life and generic entry: analysis of the new molecular entities approved by the FDA between 1980 and 1999. J Pharm Financ Econ Policy 2008;16:67-85.
-
(2008)
J Pharm Financ Econ Policy
, vol.16
, pp. 67-85
-
-
Seoane-Vazquez, E.1
Schondelmeyer, S.2
Szeinbach, S.L.3
-
54
-
-
0742306292
-
The Hatch-Waxman Act: History, structure, and legacy
-
Weiswasser ES, Danzis SD. The Hatch-Waxman Act: history, structure, and legacy. Antitrust Law J 2003;71:585-608.
-
(2003)
Antitrust Law J
, vol.71
, pp. 585-608
-
-
Weiswasser, E.S.1
Danzis, S.D.2
-
55
-
-
84910032722
-
Generics face longer wait time for approval
-
February 19
-
Singer N. Generics face longer wait time for approval. New York Times. February 19, 2010:B3.
-
(2010)
New York Times
-
-
Singer, N.1
-
56
-
-
33751213872
-
Paying for delay: Pharmaceutical patent settlement as a regulatory design problem
-
Hemphill CS. Paying for delay: pharmaceutical patent settlement as a regulatory design problem. N Y Univ Law Rev 2006;81:1553-623.
-
(2006)
N Y Univ Law Rev
, vol.81
, pp. 1553-1623
-
-
Hemphill, C.S.1
-
57
-
-
66749185380
-
A new history and discussion of 180-day exclusivity
-
Korn DE, Lietzan E, Scott SW. A new history and discussion of 180-day exclusivity. Food Drug Law J 2009;64:335-90.
-
(2009)
Food Drug Law J
, vol.64
, pp. 335-390
-
-
Korn, D.E.1
Lietzan, E.2
Scott, S.W.3
-
58
-
-
23444458067
-
The Prescription Drug User Fee Act: Is a faster Food and Drug Administration always a better Food and Drug Administration?
-
Zelenay JL Jr. The Prescription Drug User Fee Act: is a faster Food and Drug Administration always a better Food and Drug Administration? Food Drug Law J 2005;60:261-338.
-
(2005)
Food Drug Law J
, vol.60
, pp. 261-338
-
-
Zelenay Jr., J.L.1
-
59
-
-
0030033574
-
The Prescription Drug User Fee Act of 1992: A 5-year experiment for the industry and the FDA
-
Shulman SR, Kaitin KI. The Prescription Drug User Fee Act of 1992: a 5-year experiment for the industry and the FDA. Pharmacoeconomics 1996;9:121-33.
-
(1996)
Pharmacoeconomics
, vol.9
, pp. 121-133
-
-
Shulman, S.R.1
Kaitin, K.I.2
-
60
-
-
0030951929
-
The Prescription Drug User Fee Act of 1992 and the new drug development process
-
Kaitin KI. The Prescription Drug User Fee Act of 1992 and the new drug development process. Am J Ther 1997;4:167-72.
-
(1997)
Am J Ther
, vol.4
, pp. 167-172
-
-
Kaitin, K.I.1
-
62
-
-
34247492509
-
PDUFA reauthorization - Drug safety's golden moment of opportunity?
-
Hennessy S, Strom BL. PDUFA reauthorization - drug safety's golden moment of opportunity? N Engl J Med 2007;356:1703-4.
-
(2007)
N Engl J Med
, vol.356
, pp. 1703-1704
-
-
Hennessy, S.1
Strom, B.L.2
-
63
-
-
14944360098
-
What ails the FDA?
-
Erratum, N Engl J Med 2005;352:2563
-
Okie S. What ails the FDA? N Engl J Med 2005;352:1063-6. [Erratum, N Engl J Med 2005;352:2563.]
-
(2005)
N Engl J Med
, vol.352
, pp. 1063-1066
-
-
Okie, S.1
-
65
-
-
0033549087
-
The safety of newly approved medicines: Do recent market removals mean there is a problem?
-
Friedman MA, Woodcock J, Lumpkin MM, Shuren JE, Hass AE, Thompson LJ. The safety of newly approved medicines: do recent market removals mean there is a problem? JAMA 1999; 281:1728-34.
-
(1999)
JAMA
, vol.281
, pp. 1728-1734
-
-
Friedman, M.A.1
Woodcock, J.2
Lumpkin, M.M.3
Shuren, J.E.4
Hass, A.E.5
Thompson, L.J.6
-
66
-
-
0035912536
-
Lotronex and the FDA: A fatal erosion of integrity
-
DOI 10.1016/S0140-6736(00)04776-0
-
Horton R. Lotronex and the FDA: a fatal erosion of integrity. Lancet 2001;357:1544-5. (Pubitemid 32488806)
-
(2001)
Lancet
, vol.357
, Issue.9268
, pp. 1544-1545
-
-
Horton, R.1
-
67
-
-
40849130153
-
The risk we bear: The effects of review speed and industry user fees on new drug safety
-
Olsen MK. The risk we bear: the effects of review speed and industry user fees on new drug safety. J Health Econ 2008;27:175-200.
-
(2008)
J Health Econ
, vol.27
, pp. 175-200
-
-
Olsen, M.K.1
-
68
-
-
41449104685
-
Drug-review deadlines and safety problems
-
Carpenter D, Zucker EJ, Avorn J. Drug-review deadlines and safety problems. N Engl J Med 2008;358:1354-61.
-
(2008)
N Engl J Med
, vol.358
, pp. 1354-1361
-
-
Carpenter, D.1
Zucker, E.J.2
Avorn, J.3
-
70
-
-
51349139638
-
Do faster Food and Drug Administration reviews adversely affect patient safety? An analysis of the 1992 Prescription Drug User Fee Act
-
Grabowski H, Wang YR. Do faster Food and Drug Administration reviews adversely affect patient safety? An analysis of the 1992 Prescription Drug User Fee Act. J Law Econ 2008;51:377-406.
-
(2008)
J Law Econ
, vol.51
, pp. 377-406
-
-
Grabowski, H.1
Wang, Y.R.2
-
71
-
-
33846101806
-
-
Working paper 06-21. Washington, DC: AEI-Brookings Joint Center for Regulatory Studies, September 2006
-
Vernon JA, Golec JH, Lutter R, Nardinelli C. FDA new drug approval times, prescription drug user fees, and R&D spending. Working paper 06-21. Washington, DC: AEI-Brookings Joint Center for Regulatory Studies, September 2006.
-
FDA New Drug Approval Times, Prescription Drug User Fees, and R&D Spending
-
-
Vernon, J.A.1
Golec, J.H.2
Lutter, R.3
Nardinelli, C.4
-
72
-
-
0642377615
-
The need for pediatric studies of allergy and asthma medications
-
Szefler SJ, Whelan G, Gleason M, Spahn JD. The need for pediatric studies of allergy and asthma medications. Curr Allergy Asthma Rep 2003;3:478-83. (Pubitemid 39359519)
-
(2003)
Current Allergy and Asthma Reports
, vol.3
, Issue.6
, pp. 478-483
-
-
Szefler, S.J.1
Whelan, G.2
Gleason, M.3
Spahn, J.D.4
-
73
-
-
0036790165
-
Oral antihypertensive trial design and analysis under the pediatric exclusivity provision
-
Pasquali SK, Sanders SP, Li JS. Oral antihypertensive trial design and analysis under the pediatric exclusivity provision. Am Heart J 2002;144:608-14.
-
(2002)
Am Heart J
, vol.144
, pp. 608-614
-
-
Pasquali, S.K.1
Sanders, S.P.2
Li, J.S.3
-
74
-
-
85031239199
-
-
21 U.S.C. § 355A(b) (1997)
-
21 U.S.C. § 355A(b) (1997).
-
-
-
-
75
-
-
40949096097
-
Improving pediatric dosing through pediatric initiatives: What we have learned
-
Rodriguez W, Selen A, Avant D, et al. Improving pediatric dosing through pediatric initiatives: what we have learned. Pediatrics 2008;121:530-9.
-
(2008)
Pediatrics
, vol.121
, pp. 530-539
-
-
Rodriguez, W.1
Selen, A.2
Avant, D.3
-
76
-
-
34250880825
-
Stimulation programs for pediatric drug research - Do children really benefit?
-
Boots I, Sukhai RN, Klein RH, et al. Stimulation programs for pediatric drug research - do children really benefit? Eur J Pediatr 2007;166:849-55.
-
(2007)
Eur J Pediatr
, vol.166
, pp. 849-855
-
-
Boots, I.1
Sukhai, R.N.2
Klein, R.H.3
-
77
-
-
42049113033
-
Pediatric antihypertensive trial failures: Analysis of end points and dose range
-
DOI 10.1161/HYPERTENSIONAHA.107.108886, PII 0000426820080400000009
-
Benjamin DK Jr, Smith PB, Jadhav P, et al. Pediatric antihypertensive trial failures: analysis of end points and dose range. Hypertension 2008;51:834-40. (Pubitemid 351654692)
-
(2008)
Hypertension
, vol.51
, Issue.4
, pp. 834-840
-
-
Benjamin Jr., D.K.1
Smith, P.B.2
Jadhav, P.3
Gobburu, J.V.4
Murphy, M.D.5
Hasselblad, V.6
Baker-Smith, C.7
Califf, R.M.8
Li, J.S.9
-
78
-
-
33748646758
-
Peer-reviewed publication of clinical trials completed for pediatric exclusivity
-
Benjamin DK Jr, Smith PB, Murphy MD, et al. Peer-reviewed publication of clinical trials completed for pediatric exclusivity. JAMA 2006;296:1266-73.
-
(2006)
JAMA
, vol.296
, pp. 1266-1273
-
-
Benjamin Jr., D.K.1
Smith, P.B.2
Murphy, M.D.3
-
79
-
-
33645100012
-
Child and adolescent psychopharmacology in the new millennium: A workshop for academia, industry, and government
-
DeVeaugh-Geiss J, March J, Shapiro M, et al. Child and adolescent psychopharmacology in the new millennium: a workshop for academia, industry, and government. J Am Acad Child Adolesc Psychiatry 2006;45:261-70.
-
(2006)
J Am Acad Child Adolesc Psychiatry
, vol.45
, pp. 261-270
-
-
DeVeaugh-Geiss, J.1
March, J.2
Shapiro, M.3
-
80
-
-
33846878293
-
Economic return of clinical trials performed under the pediatric exclusivity program
-
Li JS, Eisenstein EL, Grabowski HG, et al. Economic return of clinical trials performed under the pediatric exclusivity program. JAMA 2007;297:480-8.
-
(2007)
JAMA
, vol.297
, pp. 480-488
-
-
Li, J.S.1
Eisenstein, E.L.2
Grabowski, H.G.3
-
81
-
-
53149083426
-
The economic returns of pediatric clinical trials of antihypertensive drugs
-
Baker-Smith CM, Benjamin DK Jr, Grabowski HG, et al. The economic returns of pediatric clinical trials of antihypertensive drugs. Am Heart J 2008;156:682-8.
-
(2008)
Am Heart J
, vol.156
, pp. 682-688
-
-
Baker-Smith, C.M.1
Benjamin Jr., D.K.2
Grabowski, H.G.3
-
83
-
-
85031269579
-
-
Sen. Hatch (Utah). Cong. Rec. S14254 (11 Oct. 1984)
-
Sen. Hatch (Utah). Cong. Rec. S14254 (11 Oct. 1984).
-
-
-
|