-
1
-
-
85052356323
-
-
21 CFR § 312.21(a). FDA
-
Food and Drug Administration. Phases of an investigation: phase 1. 21 CFR § 312.21(a). FDA, 2014.
-
(2014)
Phases of an Investigation: Phase 1
-
-
-
2
-
-
85052356323
-
-
21 CFR § 312.21(b). FDA
-
Food and Drug Administration. Phases of an investigation: phase 2. 21 CFR § 312.21(b). FDA, 2014.
-
(2014)
Phases of an Investigation: Phase 2
-
-
-
3
-
-
85052356323
-
-
21 CFR § 312.21(c). FDA
-
Food and Drug Administration. Phases of an investigation: phase 3. 21 CFR § 312.21(c). FDA, 2014.
-
(2014)
Phases of an Investigation: Phase 3
-
-
-
4
-
-
84896973049
-
New FDA breakthrough-drug category-implications for patients
-
Darrow JJ, Avorn J, Kesselheim AS. New FDA breakthrough-drug category-implications for patients. N Engl J Med 2014;370:1252-8.
-
(2014)
N Engl J Med
, vol.370
, pp. 1252-1258
-
-
Darrow, J.J.1
Avorn, J.2
Kesselheim, A.S.3
-
6
-
-
79958036418
-
Characteristics of clinical trials to support approval of orphan vs nonorphan drugs for cancer
-
Kesselheim AS, Myers JA, Avorn J. Characteristics of clinical trials to support approval of orphan vs nonorphan drugs for cancer. JAMA 2011;305:2320-26.
-
(2011)
JAMA
, vol.305
, pp. 2320-2326
-
-
Kesselheim, A.S.1
Myers, J.A.2
Avorn, J.3
-
7
-
-
0000124662
-
Investigational new drug, antibiotic, and biological drug product regulations: Procedures for drugs intended to treat life-threatening and severely debilitating illnesses
-
Food and Drug Administration, DHHS. Investigational new drug, antibiotic, and biological drug product regulations: procedures for drugs intended to treat life-threatening and severely debilitating illnesses. Fed Regist 1988;53:41516.
-
(1988)
Fed Regist
, vol.53
-
-
Food and Drug Administration, DHHS,1
-
8
-
-
0027117969
-
New drug, antibiotic, and biological drug product regulations; accelerated approval
-
Food and Drug Administration, DHHS. New drug, antibiotic, and biological drug product regulations; accelerated approval. Fed Regist 1992;57:58942-60.
-
(1992)
Fed Regist
, vol.57
, pp. 58942-58960
-
-
Food and Drug Administration, DHHS,1
-
9
-
-
0346419789
-
From investigation to marketplace: Moving drugs through the system
-
Halperin JA. From investigation to marketplace: moving drugs through the system. Food Drug Cosmet Law J 1981;36:166-74.
-
(1981)
Food Drug Cosmet Law J
, vol.36
, pp. 166-174
-
-
Halperin, J.A.1
-
10
-
-
84947256285
-
Prescription drug user fee act of 1992
-
Prescription Drug User Fee Act of 1992. 138 Cong Rec H9095, 1992.
-
(1992)
138 Cong Rec H9095
-
-
-
12
-
-
84922704898
-
The roles of academia, rare diseases, and repurposing in the development of the most transformative drugs
-
Kesselheim AS, Tan YT, Avorn J. The roles of academia, rare diseases, and repurposing in the development of the most transformative drugs. Health Aff (Millwood) 2015;34:286-94.
-
(2015)
Health Aff (Millwood)
, vol.34
, pp. 286-294
-
-
Kesselheim, A.S.1
Tan, Y.T.2
Avorn, J.3
-
13
-
-
84876802600
-
Surrogate outcomes in clinical trials: A cautionary tale
-
Svensson S, Menkes DB, Lexchin J. Surrogate outcomes in clinical trials: a cautionary tale. JAMA Intern Med 2013;173:611-2.
-
(2013)
JAMA Intern Med
, vol.173
, pp. 611-612
-
-
Svensson, S.1
Menkes, D.B.2
Lexchin, J.3
-
15
-
-
79958042183
-
-
FDA, Jun 21
-
Food and Drug Administration. Mylotarg (gemtuzumab ozogamicin): market withdrawal. FDA, Jun 21, 2010. www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm216458.htm.
-
(2010)
Mylotarg (gemtuzumab Ozogamicin): Market Withdrawal
-
-
-
16
-
-
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
-
17
-
-
84870574171
-
New drugs and safety: What happened to new active substances approved in Canada between 1995 and 2010?
-
Lexchin J. New drugs and safety: what happened to new active substances approved in Canada between 1995 and 2010? Arch Intern Med 2012;172:1680-1.
-
(2012)
Arch Intern Med
, vol.172
, pp. 1680-1681
-
-
Lexchin, J.1
-
18
-
-
40849130153
-
The risk we bear: The effects of review speed and industry user fees on new drug safety
-
Olson 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
-
-
Olson, M.K.1
-
19
-
-
84902016054
-
Regulation of investigational new drugs: "giant step for the sick and dying"?
-
Nelson RJ. Regulation of investigational new drugs: "giant step for the sick and dying"? Georgetown Law J 1988;77:463-84.
-
(1988)
Georgetown Law J
, vol.77
, pp. 463-484
-
-
Nelson, R.J.1
-
21
-
-
84903532987
-
Drug development and FDA approval, 1938-2013
-
Darrow JJ, Kesselheim AS. Drug development and FDA approval, 1938-2013. N Engl J Med 2014;370:e39.
-
(2014)
N Engl J Med
, vol.370
, pp. e39
-
-
Darrow, J.J.1
Kesselheim, A.S.2
-
22
-
-
0001257846
-
Biological products; bacterial vaccines and toxoids; implementation of efficacy review
-
Food and Drug Administration, DHHS. Biological products; bacterial vaccines and toxoids; implementation of efficacy review. Fed Regist 1985;240: 51002-117.
-
(1985)
Fed Regist
, vol.240
, pp. 51002-51117
-
-
Food and Drug Administration, DHHS,1
-
23
-
-
84884271849
-
An improved approach to measuring drug innovation finds steady rates of first-in-class pharmaceuticals, 1987-2011
-
Lanthier M, Miller KL, Nardinelli C, et al. An improved approach to measuring drug innovation finds steady rates of first-in-class pharmaceuticals, 1987-2011. Health Aff (Millwood) 2013;32: 1433-9.
-
(2013)
Health Aff (Millwood)
, vol.32
, pp. 1433-1439
-
-
Lanthier, M.1
Miller, K.L.2
Nardinelli, C.3
-
25
-
-
0026666180
-
Changes in FDA drugclassification and priority review policy
-
Crawford S. Changes in FDA drugclassification and priority review policy. Am J Hosp Pharm 1992;49:2383-6.
-
(1992)
Am J Hosp Pharm
, vol.49
, pp. 2383-2386
-
-
Crawford, S.1
-
27
-
-
0029555624
-
The food and drug administration's early access and fast track approval initiatives: How have they worked?
-
Shulman SR, Brown JS. The Food and Drug Administration's early access and fast track approval initiatives: how have they worked? Food Drug Law J 1995;50:503-31.
-
(1995)
Food Drug Law J
, vol.50
, pp. 503-531
-
-
Shulman, S.R.1
Brown, J.S.2
-
29
-
-
84947211038
-
-
DHHS
-
Food and Drug Administration, DHHS. CDER drug and biologic accelerated approvals as of September 30, 2011. www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/UCM278506.pdf.
-
(2011)
CDER Drug and Biologic Accelerated Approvals as of September 30
-
-
-
31
-
-
84930661581
-
Why do cancer drugs get such an easy ride?
-
Light DW, Lexchin J. Why do cancer drugs get such an easy ride? BMJ 2015;350:h2068.
-
(2015)
BMJ
, vol.350
-
-
Light, D.W.1
Lexchin, J.2
-
32
-
-
84892701195
-
The accelerated approval of oncologic drugs: Lessons from ponatinib
-
Prasad V, Mailankody S. The accelerated approval of oncologic drugs: lessons from ponatinib. JAMA 2014;311:353-4.
-
(2014)
JAMA
, vol.311
, pp. 353-354
-
-
Prasad, V.1
Mailankody, S.2
-
33
-
-
79955445696
-
Accelerated approval of oncology products: The food and drug administration experience
-
Johnson JR, Ning YM, Farrell A, Justice R, Keegan P, Pazdur R. Accelerated approval of oncology products: the food and drug administration experience. J Natl Cancer Inst 2011;103:636-44.
-
(2011)
J Natl Cancer Inst
, vol.103
, pp. 636-644
-
-
Johnson, J.R.1
Ning, Y.M.2
Farrell, A.3
Justice, R.4
Keegan, P.5
Pazdur, R.6
-
34
-
-
84880160766
-
The food and drug administration amendments act and postmarketing commitments
-
Fain K, Daubresse M, Alexander GC. The Food and Drug Administration Amendments Act and postmarketing commitments. JAMA 2013;310:202-4.
-
(2013)
JAMA
, vol.310
, pp. 202-204
-
-
Fain, K.1
Daubresse, M.2
Alexander, G.C.3
-
35
-
-
84929996170
-
Health Canada's use of its priority review process for new drugs: A cohort study
-
Lexchin J. Health Canada's use of its priority review process for new drugs: a cohort study. BMJ Open 2015;5:e006816
-
(2015)
BMJ Open
, vol.5
-
-
Lexchin, J.1
-
36
-
-
77955798710
-
-
DHHS
-
Food and Drug Administration, DHHS. Drugs@FDA. www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails.
-
Drugs@FDA
-
-
-
38
-
-
84899960041
-
-
Pub L No 112-144. § 902, 126 Stat 993
-
Food and Drug Administration Safety and Innovation Act. Pub L No 112-144. § 902, 126 Stat 993, 2012.
-
(2012)
Safety and Innovation Act
-
-
-
39
-
-
84927172526
-
FDA designations for therapeutics and their impact on drug development and regulatory review outcomes
-
Kesselheim AS, Darrow JJ. FDA designations for therapeutics and their impact on drug development and regulatory review outcomes. Clin Pharmacol Ther 2015;97:29-36.
-
(2015)
Clin Pharmacol Ther
, vol.97
, pp. 29-36
-
-
Kesselheim, A.S.1
Darrow, J.J.2
-
41
-
-
84947250562
-
Health policy brief: Breakthrough therapy designation
-
May 15
-
Health Policy Brief: breakthrough therapy designation. Health Aff (Millwood) May 15, 2014.
-
(2014)
Health Aff (Millwood)
-
-
-
42
-
-
84932617711
-
The 21st century cures act-will it take us back in time
-
Avorn J, Kesselheim AS. The 21st Century Cures Act-will it take us back in time. N Engl J Med 2015;372:2473-5.
-
(2015)
N Engl J Med
, vol.372
, pp. 2473-2475
-
-
Avorn, J.1
Kesselheim, A.S.2
|