Results 221 to 230 of about 690,240 (260)
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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.
Neema Navai +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.
Neema Navai +7 more
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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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Tissue Engineering, 1997
As tissue engineering products are evolving, so too are the regulatory approaches to these products. Tissue engineering product development for the United States market is facilitated by an understanding of how the U.S. Food and Drug Administration (FDA) regulates tissue engineering products.
Thomas L. Eggerman, Amy P. Patterson
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As tissue engineering products are evolving, so too are the regulatory approaches to these products. Tissue engineering product development for the United States market is facilitated by an understanding of how the U.S. Food and Drug Administration (FDA) regulates tissue engineering products.
Thomas L. Eggerman, Amy P. Patterson
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The Journal of Bone and Joint Surgery (American), 2006
Carticel is an autologous cultured chondrocyte product that has been approved by the United States Food and Drug Administration for the repair of symptomatic cartilaginous defects of the femoral condyle that are caused by acute or repetitive trauma in patients who have been previously managed with arthroscopy or other surgical procedures.
Jacquelyn A. Polder +7 more
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Carticel is an autologous cultured chondrocyte product that has been approved by the United States Food and Drug Administration for the repair of symptomatic cartilaginous defects of the femoral condyle that are caused by acute or repetitive trauma in patients who have been previously managed with arthroscopy or other surgical procedures.
Jacquelyn A. Polder +7 more
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Drug Information Journal, 1996
The way in which the Food and Drug Administration (FDA) regulates new drug development is covered. Each stage—clinical studies, the new drug application, after approval of the new drug application —is described in detail. A drug development time line is included.
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The way in which the Food and Drug Administration (FDA) regulates new drug development is covered. Each stage—clinical studies, the new drug application, after approval of the new drug application —is described in detail. A drug development time line is included.
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The Drug Regulatory System of the United States Food and Drug Administration: A Defense of Current Requirements for Safety and Efficacy [PDF]
International Journal of Health Services, 1974 The 1962 Amendments to the Food, Drug, and Cosmetic Act have substantially increased the accountability of manufacturers of new drugs, both by raising standards for clinical testing as well as requiring, for the first time, a demonstration of proof of efficacy.
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United States Food and Drug Administration’s Total Diet Study Program
2013The US launched the first total diet study in 1961 and has conducted the program continuously since then. This chapter describes the evolution of the TDS methodology used in the US, with a particular emphasis on the current sampling strategy, analytical coverage, and use of the TDS results in estimating dietary exposures.
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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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Annals of Emergency Medicine, 1995
Abstract [Burlington DB: Automatic external defibrillators and the United States Food and Drug Administration: An invited commentary. Ann Emerg Med November 1995;26:632-634.]
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Abstract [Burlington DB: Automatic external defibrillators and the United States Food and Drug Administration: An invited commentary. Ann Emerg Med November 1995;26:632-634.]
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American Journal of Ophthalmology, 2000
To update the analysis of the regulatory review interval for ophthalmic new drug applications at the United States Food and Drug Administration for the years 1997 to 1999, based on the previous review by the author of the period 1990 to 1996.Publicly available records on ophthalmic drugs approved by the Food and Drug Administration in this time period ...
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To update the analysis of the regulatory review interval for ophthalmic new drug applications at the United States Food and Drug Administration for the years 1997 to 1999, based on the previous review by the author of the period 1990 to 1996.Publicly available records on ophthalmic drugs approved by the Food and Drug Administration in this time period ...
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