-
2
-
-
0012009277
-
A history of government regulation of adulteration and misbranding of food
-
Hutt P.B., and Hutt II P.B. A history of government regulation of adulteration and misbranding of food. Food Drug Cosmetic Law J. 39 (1984) 2-73
-
(1984)
Food Drug Cosmetic Law J.
, vol.39
, pp. 2-73
-
-
Hutt, P.B.1
Hutt II, P.B.2
-
3
-
-
0016707609
-
America's first food and drug laws
-
Janssen W.F. America's first food and drug laws. FDA Consum. 9 (1975) 12-19
-
(1975)
FDA Consum.
, vol.9
, pp. 12-19
-
-
Janssen, W.F.1
-
4
-
-
33947133331
-
A history of the adulteration of food before 1906
-
Hart F.L. A history of the adulteration of food before 1906. Food Drug Cosmetic Law J. (1952) 5-22
-
(1952)
Food Drug Cosmetic Law J.
, pp. 5-22
-
-
Hart, F.L.1
-
9
-
-
0142222870
-
-
Alfred A. Knopf, New York, NY
-
Hilts P.J. Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation (2003), Alfred A. Knopf, New York, NY
-
(2003)
Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation
-
-
Hilts, P.J.1
-
10
-
-
33947120841
-
A broad concern brought before the Congress
-
Princeton University Press, Princeton, NJ
-
Young J.H. A broad concern brought before the Congress. Pure Food: Securing the Federal Food and Drugs Act of 1906 (1989), Princeton University Press, Princeton, NJ 40-65
-
(1989)
Pure Food: Securing the Federal Food and Drugs Act of 1906
, pp. 40-65
-
-
Young, J.H.1
-
11
-
-
33947147336
-
The progressive era
-
Alfred A. Knopf, New York, NY
-
Hilts P.J. The progressive era. Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation (2003), Alfred A. Knopf, New York, NY 35-55
-
(2003)
Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation
, pp. 35-55
-
-
Hilts, P.J.1
-
13
-
-
0036618481
-
Profiles in toxicology: Harvey W. Wiley
-
Stirling D.A. Profiles in toxicology: Harvey W. Wiley. Toxicol Sci. 67 (2002) 157-158
-
(2002)
Toxicol Sci.
, vol.67
, pp. 157-158
-
-
Stirling, D.A.1
-
17
-
-
33947189257
-
The law succeeds, and fails
-
Alfred A. Knopf, New York, NY
-
Hilts P.J. The law succeeds, and fails. Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation (2003), Alfred A. Knopf, New York, NY 56-71
-
(2003)
Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation
, pp. 56-71
-
-
Hilts, P.J.1
-
18
-
-
0035465069
-
Healthy public relations: The FDA's 1930 legislative campaign
-
Kay G. Healthy public relations: The FDA's 1930 legislative campaign. Bull Hist Med. 75 (2001) 446-487
-
(2001)
Bull Hist Med.
, vol.75
, pp. 446-487
-
-
Kay, G.1
-
19
-
-
33947120840
-
Capitalism in crisis
-
Alfred A. Knopf, New York, NY
-
Hilts P.J. Capitalism in crisis. Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation (2003), Alfred A. Knopf, New York, NY 72-94
-
(2003)
Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation
, pp. 72-94
-
-
Hilts, P.J.1
-
20
-
-
33947142104
-
The story of the laws behind the labels. Part II
-
Available at:. Accessed
-
Available at:. US Food and Drug Administration. The story of the laws behind the labels. Part II. Accessed. The federal Food, Drug, and Cosmetic Act (January 12, 2006). http://www.cfsan.fda.gov/lrd/historyla.html
-
(2006)
The federal Food, Drug, and Cosmetic Act
-
-
US Food and Drug Administration1
-
21
-
-
33947170668
-
Lydia Pinkham and other Washingtonians
-
December 20
-
December 20. Anderson P.Y. Lydia Pinkham and other Washingtonians. The Nation (1933) 137
-
(1933)
The Nation
, pp. 137
-
-
Anderson, P.Y.1
-
23
-
-
33947149752
-
The grand bargain
-
Alfred A. Knopf, New York, NY
-
Hilts P.J. The grand bargain. Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation (2003), Alfred A. Knopf, New York, NY 129-143
-
(2003)
Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation
, pp. 129-143
-
-
Hilts, P.J.1
-
24
-
-
33947179071
-
Thalidomide
-
Alfred A. Knopf, New York, NY
-
Hilts P.J. Thalidomide. Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation (2003), Alfred A. Knopf, New York, NY 144-165
-
(2003)
Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation
, pp. 144-165
-
-
Hilts, P.J.1
-
26
-
-
33947180593
-
The limits of policy
-
Alfred Knopf, New York, NY
-
Hilts P.J. The limits of policy. Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation (2003), Alfred Knopf, New York, NY 202-209
-
(2003)
Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation
, pp. 202-209
-
-
Hilts, P.J.1
-
28
-
-
20144370627
-
Perception and process at the Food and Drug Administration: Obligations and trade-offs in rules and guidances
-
Seiguer E., and Smith J.J. Perception and process at the Food and Drug Administration: Obligations and trade-offs in rules and guidances. Food Drug Law J. 60 (2005) 17-32
-
(2005)
Food Drug Law J.
, vol.60
, pp. 17-32
-
-
Seiguer, E.1
Smith, J.J.2
-
29
-
-
0033900333
-
A brief history of the randomized controlled trial. From oranges and lemons to the gold standard
-
vii
-
vii. Meldrum M.L. A brief history of the randomized controlled trial. From oranges and lemons to the gold standard. Hematol Oncol Clin North Am. 14 (2000) 745-760
-
(2000)
Hematol Oncol Clin North Am.
, vol.14
, pp. 745-760
-
-
Meldrum, M.L.1
-
30
-
-
0032585249
-
Controlled trials: The 1948 watershed
-
Doll R. Controlled trials: The 1948 watershed. BMJ 317 (1998) 1217-1220
-
(1998)
BMJ
, vol.317
, pp. 1217-1220
-
-
Doll, R.1
-
31
-
-
0008449758
-
Hearing procedure for refusal or withdrawal of approval of new drug applications and for issuance, amendment, or repeal of antibiotic drug regulations: Interpretative description of adequate and well-controlled clinical investigations
-
Ley Jr. H.L. Hearing procedure for refusal or withdrawal of approval of new drug applications and for issuance, amendment, or repeal of antibiotic drug regulations: Interpretative description of adequate and well-controlled clinical investigations. Fed Regist. 34 (1969) 14596-14598
-
(1969)
Fed Regist.
, vol.34
, pp. 14596-14598
-
-
Ley Jr., H.L.1
-
32
-
-
0008420020
-
Hearing regulations and regulations describing scientific content of adequate and wellcontrolled scientific investigations
-
Edwards C.C. Hearing regulations and regulations describing scientific content of adequate and wellcontrolled scientific investigations. Fed Regist. 35 (1970) 7250-7253
-
(1970)
Fed Regist.
, vol.35
, pp. 7250-7253
-
-
Edwards, C.C.1
-
34
-
-
7244236943
-
FDA: Evidentiary standards for drug development and approval
-
Katz R. FDA: Evidentiary standards for drug development and approval. NeuroRx. 1 (2004) 307-316
-
(2004)
NeuroRx.
, vol.1
, pp. 307-316
-
-
Katz, R.1
-
35
-
-
24344465285
-
FDA standards-good enough for government work?
-
Avorn J. FDA standards-good enough for government work?. N Engl J Med. 353 (2005) 969-972
-
(2005)
N Engl J Med.
, vol.353
, pp. 969-972
-
-
Avorn, J.1
-
36
-
-
0037374498
-
The price of innovation: New estimates of drug development costs
-
DiMasi J.A., Hansen R.W., and Grabowski H.G. The price of innovation: New estimates of drug development costs. J Health Econ. 22 (2003) 151-185
-
(2003)
J Health Econ.
, vol.22
, pp. 151-185
-
-
DiMasi, J.A.1
Hansen, R.W.2
Grabowski, H.G.3
-
38
-
-
33947097573
-
Rebuilding big pharma's business model
-
Available at:. Accessed
-
Available at:. Gilbert J., Henske P., and Singh A. Rebuilding big pharma's business model. Accessed. In vivo: The Business and Medicine Report (September 9, 2006). http://www.bain.com/bainweb/PDFs/cms/Marketing/rebuilding_big_pharma.pdf
-
(2006)
In vivo: The Business and Medicine Report
-
-
Gilbert, J.1
Henske, P.2
Singh, A.3
-
39
-
-
0034702265
-
The pharmaceutical industry-to whom is it accountable?
-
Angell M. The pharmaceutical industry-to whom is it accountable?. N Engl J Med. 342 (2000) 1902-1904
-
(2000)
N Engl J Med.
, vol.342
, pp. 1902-1904
-
-
Angell, M.1
-
40
-
-
78649601390
-
-
Available at:. Accessed
-
Available at:. Eisenberg R.S. The role of FDA in innovation policy. Accessed (January 6, 2007). http://www.utexas.edu/law/academica/centers/clbe/assets/FDAinnovation_draft.pdf
-
(2007)
The role of FDA in innovation policy
-
-
Eisenberg, R.S.1
-
44
-
-
16544389833
-
Approval times for new drugs: Does the source of funding for FDA staff matter?
-
Suppl Web Exclusives:W3-618-W3-624
-
Suppl Web Exclusives:W3-618-W3-624. Carpenter D., Chernew M., Smith D.G., and Fendrick A.M. Approval times for new drugs: Does the source of funding for FDA staff matter?. Health Aff (Millwood) (2003)
-
(2003)
Health Aff (Millwood)
-
-
Carpenter, D.1
Chernew, M.2
Smith, D.G.3
Fendrick, A.M.4
-
45
-
-
16544388559
-
Explaining reductions in FDA drug review times: PDUFA matters
-
Suppl Web Exclusives:W4-Sl-W4-S2
-
Suppl Web Exclusives:W4-Sl-W4-S2. Olson M.K. Explaining reductions in FDA drug review times: PDUFA matters. Health Aff (Millwood) (2003)
-
(2003)
Health Aff (Millwood)
-
-
Olson, M.K.1
-
46
-
-
16544366030
-
Crisis deepens at the US Food and Drug Administration
-
Lenzer J. Crisis deepens at the US Food and Drug Administration. BMJ. 329 (2004) 1308
-
(2004)
BMJ.
, vol.329
, pp. 1308
-
-
Lenzer, J.1
-
47
-
-
28044458146
-
Politics trumps science at the FDA
-
Politics trumps science at the FDA. Lancet 366 (2005) 1827
-
(2005)
Lancet
, vol.366
, pp. 1827
-
-
-
48
-
-
28944433326
-
A sad day for science at the FDA
-
Burstein P.D. A sad day for science at the FDA. N Engl J Med. 353 (2005) 2619-2621
-
(2005)
N Engl J Med.
, vol.353
, pp. 2619-2621
-
-
Burstein, P.D.1
-
49
-
-
27944506925
-
Pessimistic response to FDA leadership change [published correction appears in Nat Biotechnol. 2006;24:220]
-
Kling J. Pessimistic response to FDA leadership change [published correction appears in Nat Biotechnol. 2006;24:220]. Nat Biotechnol. 23 (2005) 1325
-
(2005)
Nat Biotechnol.
, vol.23
, pp. 1325
-
-
Kling, J.1
-
50
-
-
13444311031
-
FDA is incapable of protecting US "against another Vioxx."
-
Lenzer J. FDA is incapable of protecting US "against another Vioxx.". BMJ. 329 (2004) 1253
-
(2004)
BMJ.
, vol.329
, pp. 1253
-
-
Lenzer, J.1
-
51
-
-
27744472227
-
Continuing concerns over acting FDA commissioner
-
Nelson R. Continuing concerns over acting FDA commissioner. Lancet Oncol. 6 (2005) 827
-
(2005)
Lancet Oncol.
, vol.6
, pp. 827
-
-
Nelson, R.1
-
52
-
-
25844458489
-
What is going on at the FDA?
-
What is going on at the FDA?. Lancet 366 (2005) 1137
-
(2005)
Lancet
, vol.366
, pp. 1137
-
-
-
53
-
-
27344451233
-
Chess game at the FDA
-
Kennedy D. Chess game at the FDA. Science 310 (2005) 589
-
(2005)
Science
, vol.310
, pp. 589
-
-
Kennedy, D.1
-
54
-
-
27844584320
-
Many issues in store for new FDA commissioner
-
Wadman M. Many issues in store for new FDA commissioner. Nat Rev Drug Discov. 4 (2005) 871-872
-
(2005)
Nat Rev Drug Discov.
, vol.4
, pp. 871-872
-
-
Wadman, M.1
|