-
1
-
-
84930164470
-
-
Updated June 8, Accessed June 15, 2015
-
US Food and Drug Administration. Developing products for rare diseases and conditions. http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm. Updated June 8, 2015. Accessed June 15, 2015.
-
(2015)
Developing Products for Rare Diseases and Conditions
-
-
-
3
-
-
84873079257
-
Orphan drugs: The regulatory environment
-
Franco P. Orphan drugs: the regulatory environment. Drug Discov Today. 2013;18(3-4):165.
-
(2013)
Drug Discov Today
, vol.18
, Issue.3-4
, pp. 165
-
-
Franco, P.1
-
4
-
-
84894047266
-
Orphan drug act
-
Pub L 97-414
-
Orphan Drug Act, Pub L No. 97-414, 96 Stat 2049-2057.
-
Stat
, vol.96
, pp. 2049-2057
-
-
-
5
-
-
85064165796
-
-
Field
-
Field, Boat, 25.
-
Boat
, pp. 25
-
-
-
6
-
-
84864198277
-
Orphan drugs for rare diseases: Is it time to revisit their special market access status?
-
Simoens S, Cassiman D, Dooms M, Picavet E. Orphan drugs for rare diseases: is it time to revisit their special market access status? Drugs. 2012;72(11):1437-1443.
-
(2012)
Drugs
, vol.72
, Issue.11
, pp. 1437-1443
-
-
Simoens, S.1
Cassiman, D.2
Dooms, M.3
Picavet, E.4
-
7
-
-
85064175317
-
-
as amended): last updated August Updated June 8, 2015. Accessed June 15, 2015
-
US Food and Drug Administration. Orphan Drug Act: relevant excerpts (Public Law 97-414, as amended): last updated August 2013. http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/HowtoapplyforOrphanProductDesignation/ucm364750.htm. Updated June 8, 2015. Accessed June 15, 2015.
-
(2013)
Orphan Drug Act: Relevant Excerpts (Public Law 97-414
-
-
-
8
-
-
77950937284
-
The US orphan drug act: Rare disease research stimulator or commercial opportunity?
-
Wellman-Labadie O, Zhou Y. The US Orphan Drug Act: rare disease research stimulator or commercial opportunity? Health Policy. 2010;95(2-3):226.
-
(2010)
Health Policy
, vol.95
, Issue.2-3
, pp. 226
-
-
Wellman-Labadie, O.1
Zhou, Y.2
-
9
-
-
85064173049
-
-
Field
-
Field, Boat, 36.
-
Boat
, pp. 36
-
-
-
10
-
-
84872358725
-
The impact of new (orphan) drug approvals on premature mortality from rare diseases in the United States and France, 1999-2007
-
Lichtenberg FR. The impact of new (orphan) drug approvals on premature mortality from rare diseases in the United States and France, 1999-2007. Eur J Health Econ. 2013;14(1):41-56.
-
(2013)
Eur J Health Econ
, vol.14
, Issue.1
, pp. 41-56
-
-
Lichtenberg, F.R.1
-
11
-
-
0344646774
-
-
Cambridge, MA: National Bureau of Economic Research; NBER Working Paper 8677. Accessed June 17, 2015
-
Lichtenberg FR. The effect of new drugs on mortality from rare diseases and HIV. Cambridge, MA: National Bureau of Economic Research; 2001. NBER Working Paper 8677. http://www.nber.org/papers/w8677.pdf. Accessed June 17, 2015.
-
(2001)
The Effect of New Drugs on Mortality from Rare Diseases and HIV
-
-
Lichtenberg, F.R.1
-
13
-
-
84871184065
-
What is wrong with orphan drug policies?
-
Cȏté A, Keating B. What is wrong with orphan drug policies? Value Health. 2012;15(8):1185-1191.
-
(2012)
Value Health
, vol.15
, Issue.8
, pp. 1185-1191
-
-
Cȏté, A.1
Keating, B.2
-
14
-
-
44849139068
-
Does orphan drug legislation really answer the needs of patients?
-
Haffner ME, Torrent-Farnell J, Maher PD. Does orphan drug legislation really answer the needs of patients? Lancet. 2008;371(9629):2041-2044.
-
(2008)
Lancet
, vol.371
, Issue.9629
, pp. 2041-2044
-
-
Haffner, M.E.1
Torrent-Farnell, J.2
Maher, P.D.3
-
15
-
-
79958849417
-
Pricing and reimbursement of orphan drugs: The need for more transparency
-
Simoens S. Pricing and reimbursement of orphan drugs: the need for more transparency. Orphanet J Rare Dis. 2011;6:42.
-
(2011)
Orphanet J Rare Dis
, vol.6
, pp. 42
-
-
Simoens, S.1
-
17
-
-
77954174838
-
Extraordinary pricing of orphan drugs: Is it a socially responsible strategy for the US pharmaceutical industry?
-
Hemphill TA. Extraordinary pricing of orphan drugs: is it a socially responsible strategy for the US pharmaceutical industry? J Bus Ethics. 2010;94:229.
-
(2010)
J Bus Ethics
, vol.94
, pp. 229
-
-
Hemphill, T.A.1
-
18
-
-
37349006685
-
The off-label use of drugs in oncology: A position paper by the european society for medical oncology (ESMO)
-
Casali PG; Executive Committee of ESMO. The off-label use of drugs in oncology: a position paper by the European Society for Medical Oncology (ESMO). Ann Oncol. 2007;18(12):1923-1925.
-
(2007)
Ann Oncol
, vol.18
, Issue.12
, pp. 1923-1925
-
-
Casali, P.G.1
-
19
-
-
72949104955
-
The oncology pipeline: Maturing, competitive, and growing?
-
September
-
Gavel SJ. The oncology pipeline: maturing, competitive, and growing? Oncol Bus Rev. September 2008:14-16.
-
(2008)
Oncol Bus Rev
, pp. 14-16
-
-
Gavel, S.J.1
-
20
-
-
0027139178
-
Senators seek reform of orphan drug act
-
Seachrist L. Senators seek reform of Orphan Drug Act. J Natl Cancer Inst. 1993;85(24):1984-1985.
-
(1993)
J Natl Cancer Inst
, vol.85
, Issue.24
, pp. 1984-1985
-
-
Seachrist, L.1
-
23
-
-
85064184567
-
-
Cȏté
-
Cȏté, Keating, 1185.
-
Keating
, pp. 1185
-
-
|