Results 161 to 170 of about 478,778 (207)

United States Food and Drug Administration Regulation of Gene and Cell Therapies

2015
The United States (US) Food and Drug Administration (FDA) is a regulatory agency that has oversight for a wide range of products entering the US market, including gene and cell therapies. The regulatory approach for these products is similar to other medical products within the United States and consists of a multitiered framework of statutes ...
Judith Arcidiacono, Steve Winitsky, Zenobia Taraporewala, Alexander M. Bailey, Kimberly A Benton   +4 more
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What's new on nutrition labeling at the United States Food and Drug Administration?

Journal of Food Composition and Analysis, 2003
Abstract The manuscript provides an overview of food labeling activities of the United States (USA) Food and Drug Administration (FDA). Highlights include: • FDA will proceed with final rulemaking on trans fatty acid labeling after review of the National Academy of Sciences (NAS) Macronutrient Report.
Mary Bender Brandt, Lori A. LeGault
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Prohibited or regulated? LSD psychotherapy and the United States Food and Drug Administration

History of Psychiatry, 2016
Over the 1950s and early 1960s, the use of the hallucinogenic drug lysergic acid diethylamide (LSD) to facilitate psychotherapy was a promising field of psychiatric research in the USA. However, during the 1960s, research began to decline, before coming to a complete halt in the mid-1970s.
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U.S. Food and Drug Administration Drug Approval

Obstetrics & Gynecology, 2010
The process for drug approval in the United States is complex and time-consuming. There are comparatively few drugs with U.S. Food and Drug Administration (FDA)-approved indications for obstetric use in this country at this time; however, several are under development.
Durlin E. Hickok, Barbara L. Powers, Deborah A. Wing   +2 more
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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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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 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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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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