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1
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0028279141
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The new drug approvals of 1990, 1991, and 1992: Trends in drug development
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Kaitin KI, Manocchia M, Seibring M, Lasagna L: The new drug approvals of 1990, 1991, and 1992: Trends in drug development. J Clin Pharmacol 1994;34:120-127.
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(1994)
J Clin Pharmacol
, vol.34
, pp. 120-127
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Kaitin, K.I.1
Manocchia, M.2
Seibring, M.3
Lasagna, L.4
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2
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0026099268
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The new drug approvals of 1987, 1988, and 1989: Trends in drug development
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Kaitin KI, DiCerbo PA, Lasagna L: The new drug approvals of 1987, 1988, and 1989: Trends in drug development. J Clin Pharmacol 1991;31:116-122.
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(1991)
J Clin Pharmacol
, vol.31
, pp. 116-122
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Kaitin, K.I.1
DiCerbo, P.A.2
Lasagna, L.3
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3
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0023176872
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Trends in drug development: The 1985-86 new drug approvals
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Kaitin KI, Richard BW, Lasagna L: Trends in drug development: The 1985-86 new drug approvals. J Clin Pharmacol 1987;27:542-548.
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(1987)
J Clin Pharmacol
, vol.27
, pp. 542-548
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Kaitin, K.I.1
Richard, B.W.2
Lasagna, L.3
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7
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1842375152
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Pharmaceutical Research and Manufacturers of America, Washington DC, May
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The Patient Is Waiting. Pharmaceutical Research and Manufacturers of America, Washington DC, May 1996.
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(1996)
The Patient Is Waiting
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10
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0343427072
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Pub Law 102-571 Oct 29; 21 USC 379; 106 Stat 4491
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Prescription Drug User Fee Act of 1992. Pub Law 102-571 (1992 Oct 29); 21 USC 379; 106 Stat 4491.
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(1992)
Prescription Drug User Fee Act of 1992
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13
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0030033574
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The Prescription Drug User Fee Act of 1992: A five-year experiment for industry and the FDA
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Shulman SR, Kaitin KI: The Prescription Drug User Fee Act of 1992: A five-year experiment for industry and the FDA. Pharmacol Econ 1996;9:121-133.
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(1996)
Pharmacol Econ
, vol.9
, pp. 121-133
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Shulman, S.R.1
Kaitin, K.I.2
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14
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0027324578
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The role of the research-based pharmaceutical industry in medical progress in the United States
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Kaitin KI, Bryant NR, Lasagna L: The role of the research-based pharmaceutical industry in medical progress in the United States. J Clin Pharmacol 1993;33:412-417.
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(1993)
J Clin Pharmacol
, vol.33
, pp. 412-417
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Kaitin, K.I.1
Bryant, N.R.2
Lasagna, L.3
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15
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85036440587
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A new look at U.S. drug development and approval times
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In press
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DiMasi JA: A new look at U.S. drug development and approval times. Am J Therapeutics. In press.
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Am J Therapeutics
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DiMasi, J.A.1
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16
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0031050791
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FDA reform: Setting the stage for efforts to reform the Agency
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Kaitin KI: FDA reform: Setting the stage for efforts to reform the Agency. Drug Inf J. 1997;31:27-33.
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(1997)
Drug Inf J
, vol.31
, pp. 27-33
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Kaitin, K.I.1
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18
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85036442632
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Accelerated approval of new drugs for serious or life-threatening illnesses. 21 CFR 314.500
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Accelerated approval of new drugs for serious or life-threatening illnesses. 21 CFR 314.500.
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19
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85036447253
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Accelerated approval of biological products for serious or life-threatening illnesses. 21 CFR 601.40
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Accelerated approval of biological products for serious or life-threatening illnesses. 21 CFR 601.40.
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20
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0029555624
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The Food and Drug Administration's early access and fast-track approval initiatives: How have they worked?
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Shulman SR, Brown JS: The Food and Drug Administration's early access and fast-track approval initiatives: How have they worked? Food Drug Law 1995;50:503-532.
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(1995)
Food Drug Law
, vol.50
, pp. 503-532
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Shulman, S.R.1
Brown, J.S.2
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21
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0026691466
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Are initiatives to speed the new drug approval process working?
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Kaitin KI, Walsh HL, Lasagna L: Are initiatives to speed the new drug approval process working? Drug Inf J 1992;26:341-349.
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(1992)
Drug Inf J
, vol.26
, pp. 341-349
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Kaitin, K.I.1
Walsh, H.L.2
Lasagna, L.3
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23
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33846942570
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US FDA to automate all NDAs by 1995
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US FDA to automate all NDAs by 1995. Scrip 1991;1641: 17.
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(1991)
Scrip
, vol.1641
, pp. 17
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25
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0029059520
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A drug lag update. In White paper on four areas of relevance to new drug development and review in the United States
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Kaitin KI, Brown JS: A drug lag update. In White paper on four areas of relevance to new drug development and review in the United States. Drug Inf J 1995;29:361-373.
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(1995)
Drug Inf J
, vol.29
, pp. 361-373
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Kaitin, K.I.1
Brown, J.S.2
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26
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0024467891
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The drug lag: An update of new drug introductions in the United States and the United Kingdom, 1977 through 1987
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Kaitin KI, Mattison N, Northington FK, Lasagna L: The drug lag: An update of new drug introductions in the United States and the United Kingdom, 1977 through 1987. Clin Pharmacol Ther 1989;46:121-138.
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(1989)
Clin Pharmacol Ther
, vol.46
, pp. 121-138
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Kaitin, K.I.1
Mattison, N.2
Northington, F.K.3
Lasagna, L.4
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27
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0015896840
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Introduction of new therapeutic drugs in the United States and Great Britain: An international comparison
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Wardell WM: Introduction of new therapeutic drugs in the United States and Great Britain: an international comparison. Clin Pharmacol Ther 1973;14:773-790.
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(1973)
Clin Pharmacol Ther
, vol.14
, pp. 773-790
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Wardell, W.M.1
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29
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85036448144
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America's rapid access to new drugs: An international comparison
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In press
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and Kessler DA, Haas AE, Fieden KL, et al.: America's rapid access to new drugs: an international comparison. J Am Med Assoc. In press.
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J Am Med Assoc.
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Kessler, D.A.1
Haas, A.E.2
Fieden, K.L.3
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