-
1
-
-
84886119679
-
-
A History of the FDA@ FDA.gov
-
A History of the FDA@ FDA.gov, http://www.fda.gov/AboutFDA/WhatWeDo/History/Origin/ucm054819.htm
-
-
-
-
2
-
-
84886165414
-
-
http:www.thalidomidesociety.co.uk/thalhistory.htm
-
-
-
-
3
-
-
0343176197
-
Drug embryopathy: the thalidomide story
-
Kelsey FO. Drug embryopathy: the thalidomide story. MD State Med J 1963;12: 594-597
-
(1963)
MD State Med J
, vol.12
, pp. 594-597
-
-
Kelsey, F.O.1
-
4
-
-
0037108228
-
Policy developments in regulatory approval
-
Temple R. Policy developments in regulatory approval. Stat Med 2002;21:2939-2948
-
(2002)
Stat Med
, vol.21
, pp. 2939-2948
-
-
Temple, R.1
-
5
-
-
84886158975
-
-
Pediatric Rule, Federal Register, 59FR64240; 1994 Dec 13
-
Pediatric Rule, Federal Register, 59FR64240; 1994 Dec 13
-
-
-
-
6
-
-
0000358397
-
The Pediatric rule, regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients, final rule.
-
Anon., The Pediatric rule, regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients, final rule. Fed Regist 1998;63(231):66632-66672
-
(1998)
Fed Regist
, vol.63
, Issue.231
, pp. 66632-66672
-
-
Anon1
-
7
-
-
84886226092
-
-
Pediatric Research Equity Act (PREA). Available at December 2003
-
Pediatric Research Equity Act (PREA). Available at http://www.fda.gov/opacom/ laws.pres.html. December 2003
-
-
-
-
8
-
-
84886119078
-
-
FDAMA. Pub. S.1789, Best pharmaceuticals for children Act; 21 USC 355a. 2001 Jan 3
-
FDAMA. Pub. S.1789, Best pharmaceuticals for children Act; 21 USC 355a. 2001 Jan 3
-
-
-
-
9
-
-
84886153958
-
-
Presentation, pediatric market US. Information on file at tufts center for pediatric development. 2003 March
-
Durant D. Presentation, pediatric market US. Information on file at tufts center for pediatric development. 2003 March
-
-
-
Durant, D.1
-
10
-
-
57649147435
-
Global pediatric drug sales to top $46 Billion.
-
Anon., Global pediatric drug sales to top $46 Billion. PhRMA Mark Lett 2006;33(4):16
-
(2006)
PhRMA Mark Lett
, vol.33
, Issue.4
, pp. 16
-
-
Anon1
-
11
-
-
57649172104
-
The trials of youth, bringing children into clinical research.
-
Myshko D. The trials of youth, bringing children into clinical research. Pharmavoice 2003;3(9):42-48
-
(2003)
Pharmavoice
, vol.3
, Issue.9
, pp. 42-48
-
-
Myshko, D.1
-
13
-
-
0003680152
-
The pharmacological basis of therapeutics.
-
11th ed. New York: McGraw-Hill Medical Publishing Division;
-
Goodman and Gilman's. The pharmacological basis of therapeutics. 11th ed. New York: McGraw-Hill Medical Publishing Division; 2006. pp. 1181-1182
-
(2006)
, pp. 1181-1182
-
-
Goodman1
Gilman's2
-
14
-
-
0003680152
-
The pharmacological basis of therapeutics.
-
10th ed. New York: McGraw-Hill Medical Publishing Division;
-
Goodman and Gilman's. The pharmacological basis of therapeutics. 10th ed. New York: McGraw-Hill Medical Publishing Division; 2001. p. 1245
-
(2001)
, pp. 1245
-
-
Goodman1
Gilman's2
-
15
-
-
84886181938
-
-
Washington (DC): American Pharmaceutical Association
-
Handbook of pharmaceutical excipients. 3rd ed. Washington (DC): American Pharmaceutical Association; 2000. p. 42
-
(2000)
Handbook of pharmaceutical excipients. 3rd ed
, pp. 42
-
-
-
16
-
-
0242681944
-
History of Excipient Safety and Toxicity,
-
In: Weiner ML, Kotkoskie LA, editors, Excipient Toxicity and Safety, Marcel Dekker, Inc., New York, N.Y.,
-
Winek, C., History of Excipient Safety and Toxicity, In: Weiner ML, Kotkoskie LA, editors, Excipient Toxicity and Safety, Marcel Dekker, Inc., New York, N.Y., Vol. 103, pps. 59-72
-
, vol.103
, pp. 59-72
-
-
Winek, C.1
-
17
-
-
84886151861
-
-
FDA Part 15 Hearing on O-T-C Drugs, Docket #00N-1256, June 28, 1972
-
Greene MF. FDA Part 15 Hearing on O-T-C Drugs, Docket #00N-1256, June 28, 1972
-
-
-
Greene, M.F.1
-
18
-
-
84886123647
-
-
FDA Introduction to Total Drug Quality, DHEW Publication 74-3006, DHEW/PHS/FDA, 1973
-
Anon., FDA Introduction to Total Drug Quality, DHEW Publication 74-3006, DHEW/PHS/FDA, 1973
-
-
-
Anon1
-
19
-
-
84886172988
-
-
Redbook II. Toxicological principles for the safety assessment of direct food additives and color additives used in food. Center for Food Safety and Applied Nutition, US Food and Drug Administration; , U.S. Department of Commerce, National Technical Information Service, Springfield, VA 22161, PB 83-170696
-
Redbook II. Toxicological principles for the safety assessment of direct food additives and color additives used in food. Center for Food Safety and Applied Nutition, US Food and Drug Administration; 1993, U.S. Department of Commerce, National Technical Information Service, Springfield, VA 22161, PB 83-170696
-
(1993)
-
-
-
20
-
-
0032842520
-
Food and Drug Administration proposed testing guidelines for reproduction studies. Revision Committee.
-
Collins TF, Sprando RL, Shackelford ME, Hansen DK, Welsh JJ. Food and Drug Administration proposed testing guidelines for reproduction studies. Revision Committee. FDA Guidelines for Developmental Toxicity and Reproduction, Food and Drug Administration. Regul Toxicol Pharmacol 1999;30(1):29-38
-
(1999)
FDA Guidelines for Developmental Toxicity and Reproduction, Food and Drug Administration. Regul Toxicol Pharmacol
, vol.30
, Issue.1
, pp. 29-38
-
-
Collins, T.F.1
Sprando, R.L.2
Shackelford, M.E.3
Hansen, D.K.4
Welsh, J.J.5
-
21
-
-
0033771951
-
Concordance of the toxicity of pharmaceuticals in humans and animals.
-
Olson H, Betton G, Robinson D, Thomas K, Monro A, Kolaja G, Lilly P, Sanders J, Sipes G, Bracken W, Dorato M, Van Deun K, Smith P, Berger B, Heller A. Concordance of the toxicity of pharmaceuticals in humans and animals. Regul Toxicol Pharmacol 2000;32(1):56-67
-
(2000)
Regul Toxicol Pharmacol
, vol.32
, Issue.1
, pp. 56-67
-
-
Olson, H.1
Betton, G.2
Robinson, D.3
Thomas, K.4
Monro, A.5
Kolaja, G.6
Lilly, P.7
Sanders, J.8
Sipes, G.9
Bracken, W.10
Dorato, M.11
Van Deun, K.12
Smith, P.13
Berger, B.14
Heller, A.15
-
23
-
-
84886105264
-
-
Reviewer Guidance, Integration of Study Results to Assess Concerns about Human Reproductive and Developmental Toxicities. 2001 Oct. Copies may be available from the Drug Information Branch (HFD-210), CDER
-
Anon., Reviewer Guidance, Integration of Study Results to Assess Concerns about Human Reproductive and Developmental Toxicities. 2001 Oct. Copies may be available from the Drug Information Branch (HFD-210), CDER
-
-
-
Anon1
-
24
-
-
84886122033
-
-
FDA/CDER Guidance for Industry. Nonclinical safety evaluation of pediatric drug products. 2006 Feb. Available at
-
FDA/CDER Guidance for Industry. Nonclinical safety evaluation of pediatric drug products. 2006 Feb. Available at http://www.fda.gov/cder/guidance/index.htm
-
-
-
-
25
-
-
84886118075
-
-
FDA/CBER Guidance for Industry. Premarket assessment of pediatric medical devices. 2004 May. Available at
-
FDA/CBER Guidance for Industry. Premarket assessment of pediatric medical devices. 2004 May. Available at http://www.fda.gov/BiologicsBloodVaccines/default.htm
-
-
-
-
26
-
-
84886205137
-
-
FDA CDER/CBER Guidance for Industry. E11-clinical investigation of medicinal products in the pediatric population 2000. Available at
-
FDA CDER/CBER Guidance for Industry. E11-clinical investigation of medicinal products in the pediatric population 2000. Available at http://www.fda.gov/cder/guidance/- index.htm
-
-
-
-
27
-
-
84886204815
-
-
ICH.
-
ICH. http://www.ich.org
-
-
-
-
28
-
-
84886124912
-
-
ICH S5A
-
ICH S5A, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm065007.htm
-
-
-
-
29
-
-
0023544856
-
Teratological research using in vitro systems, V Non-mammalian model systems.
-
Collins TF. Teratological research using in vitro systems, V. Non-mammalian model systems. Environ Health Perspect 1987;72:237-249
-
(1987)
Environ Health Perspect
, vol.72
, pp. 237-249
-
-
Collins, T.F.1
-
30
-
-
20244368931
-
Survey of unlicensed and off label drug use in paediatric wards in European countries
-
Conroy S, Choonara I, Impicciatore P, Mohn A, Arnell H, Rane A, Knoeppel C, Seyberth H, Pandolfini C, Raffaelli MP, Rocchi F, Bonati M, Jong G, de Hoog M, van den Anker J. Survey of unlicensed and off label drug use in paediatric wards in European countries. Br Med J 2000;320:79-82
-
(2000)
Br Med J
, vol.320
, pp. 79-82
-
-
Conroy, S.1
Choonara, I.2
Impicciatore, P.3
Mohn, A.4
Arnell, H.5
Rane, A.6
Knoeppel, C.7
Seyberth, H.8
Pandolfini, C.9
Raffaelli, M.P.10
Rocchi, F.11
Bonati, M.12
Jong, G.13
de Hoog, M.14
van den Anker, J.15
-
31
-
-
84886140089
-
-
ICH E11
-
ICH E11, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm065004.htm
-
-
-
-
32
-
-
84886218842
-
-
Presentation: global pediatric drug development and the European pediatric initiative: A brief overview. FDA; 2007 Dec.
-
Murphy D. Presentation: global pediatric drug development and the European pediatric initiative: A brief overview. FDA; 2007 Dec.
-
-
-
Murphy, D.1
|