Results 71 to 80 of about 524,053 (116)
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European Urology, 2019
The category "BCG-unresponsive disease", formulated by experts at the request of the United States Food and Drug Administration, denotes a group of patients with recurrent non-muscle-invasive bladder cancer for whom continued BCG treatment is unlikely to provide benefit.
Roger, Li +7 more
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The category "BCG-unresponsive disease", formulated by experts at the request of the United States Food and Drug Administration, denotes a group of patients with recurrent non-muscle-invasive bladder cancer for whom continued BCG treatment is unlikely to provide benefit.
Roger, Li +7 more
openaire +2 more sources
Journal of Clinical Oncology, 2019
6513 Background: The Breakthrough Therapy program was established in July 2012 to expedite drug development and approval by the FDA. We compared the characteristics of clinical trials leading to FDA approval as well as the magnitude of clinical benefit and value framework scores of breakthrough-designated and non-breakthrough-designated cancer drugs.
Consolacion Molto +8 more
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6513 Background: The Breakthrough Therapy program was established in July 2012 to expedite drug development and approval by the FDA. We compared the characteristics of clinical trials leading to FDA approval as well as the magnitude of clinical benefit and value framework scores of breakthrough-designated and non-breakthrough-designated cancer drugs.
Consolacion Molto +8 more
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Regulatory Aspects of Microdialysis: A United States Food and Drug Administration Perspective
2012The purpose of this chapter is to illustrate the potential applications of microdialysis (MD) in drug discovery and development with the aim of meeting Food and Drug Administration (FDA) requirements for evaluating drug bioavailability (BA) and/or establishing bioequivalence (BE).
Chinmay Shukla +3 more
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2017
Over 30 years ago, the United States (US) Congress passed the Orphan Drug Act (ODA) to encourage the development of products for rare diseases or conditions ("orphan products"). The Act provided incentives to sponsors for developing products with orphan designation and established a grant program to fund studies of orphan products.
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Over 30 years ago, the United States (US) Congress passed the Orphan Drug Act (ODA) to encourage the development of products for rare diseases or conditions ("orphan products"). The Act provided incentives to sponsors for developing products with orphan designation and established a grant program to fund studies of orphan products.
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New cancer breakthrough therapies at the United States Food and Drug Administration
Journal of Hospital Management and Health Policy, 2018Cancer is an emotive word that strikes fear into many people. This is hardly surprising since premature death due to cancer is the leading cause of mortality in Canada, the United States and many other countries.
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United States Food and Drug Administration requirements for approval of generic drug products.
The Journal of clinical psychiatry, 2001As generic products become more available for the treatment of psychiatric disorders, clinicians must stay abreast of the U.S. Food and Drug Administration (FDA) requirements for the approval of generic drug products. The FDA declares that pharmaceutical equivalents only are therapeutically equivalent, and pharmacokinetic data are all that is usually ...
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2004
In general, the nonclinical studies conducted to support the development of radiopharmaceuticals should be consistent with current International Conference on Harmonization (ICH) Guidelines. The United States Food and Drug Administration (FDA), however, has recognized that certain characteristics of radiopharmaceuticals necessitate an adaptation of the
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In general, the nonclinical studies conducted to support the development of radiopharmaceuticals should be consistent with current International Conference on Harmonization (ICH) Guidelines. The United States Food and Drug Administration (FDA), however, has recognized that certain characteristics of radiopharmaceuticals necessitate an adaptation of the
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United States Food and Drug Administration TASS Program
Ophthalmology, 2013openaire +2 more sources
2012
It is now well established that subgroup populations deserve a careful assessment of their response differences in order to derive maximum benefit from medical products, and that the concept of ‘one ...
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It is now well established that subgroup populations deserve a careful assessment of their response differences in order to derive maximum benefit from medical products, and that the concept of ‘one ...
openaire +1 more source