Results 311 to 320 of about 743,931 (363)

Clinical benefit of breakthrough cancer drugs approved by the United States Food and Drug Administration.

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.
Ignasi Gich Saladich, Aaron S. Kesselheim, Eitan Amir, Consolacion Molto, Thomas J Hwang, Agust Barnadas, Maria Borrell, Marta Andrés, Ariadna Tibau Martorell   +8 more
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United States Food and Drug Administration approach to risk evaluation and risk management for foods

Regulatory Toxicology and Pharmacology, 1983
The Food and Drug Administration (FDA) is developing a comprehensive program on risk evaluation and risk management related to foods and food ingredients. Various groups view the FDA differently in terms of potential food hazards, but the regulatory agency is required to follow the laws that reflect a set of social judgments about permissible risks and
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United States Food and Drug Administration: Regulation of Vaccines

2013
Vaccine development is a complex process guided by regulatory requirements that are designed to ensure the licensure of safe and effective products. Vaccines are subject to rigorous regulatory oversight throughout their life cycle including scientific and clinical assessments.
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Regulatory Aspects of Microdialysis: A United States Food and Drug Administration Perspective

2012
The 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).
Robert Lionberger, Chinmay G. Shukla, Jing Li, Edward D. Bashaw   +3 more
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Academic perspectives on the United States food and drug administration's guidance for industry on diabetes mellitus

Contemporary Clinical Trials, 2010
The United States Food and Drug Administration (FDA) has issued Guidance for Industry, subtitled Diabetes Mellitus-Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes. From an academic perspective, these regulatory requirements provide undue emphasis on the results of phase 2 trials not designed to test hypotheses ...
Charles H. Hennekens, Patricia R. Hebert, Wendy R. Schneider, Peter C. O'Brien, Jeffrey S. Borer, David L. DeMets   +5 more
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United States Food and Drug Administration Regulation of Human Cells, Tissues, and Gene Therapies.

Advances in Experimental Medicine and Biology, 2023
Sandhya Sanduja, Liz Lessey-Morillon, Rondine J. Allen, Xiaofei Wang, Gavin Imperato, J. Arcidiacono   +5 more
semanticscholar   +1 more source

Prognostic Implication of the United States Food and Drug Administration-defined BCG-unresponsive Disease

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, H. Barton Grossman, Ashish M. Kamat, William Tabayoyong, Charles C. Guo, Graciela M. Nogueras González, Colin P.N. Dinney, Roger Li   +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, 2018
Cancer 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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The United States Food and Drug Administration Paradigm for the Regulation of Tissue-Engineered Products

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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An Overview of How the Food and Drug Administration Regulates New Drug Development in the United States

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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