Results 161 to 170 of about 760,147 (214)

The United States Food and Drug Administration’s Risk Management Framework

Drug Information Journal, 2002
In response to criticism that under the Prescription Drug User Fee Act, the United States Food and Drug Administration was endangering public health by shortening the review and approval process for medical products, former Food and Drug Administration Commissioner Jane Henney appointed a task force to evaluate the effectiveness of the Food and Drug ...
Gina Steidle, Shawn E. Hodges
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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 ...
Alexander M, Bailey, Judith, Arcidiacono, Kimberly A, Benton, Zenobia, Taraporewala, Steve, Winitsky   +4 more
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United States Food and Drug Administration Regulation of Human Cells, Tissues, and Gene Therapies

2023
Research and development of gene therapies and cell- or tissue-based therapies has experienced exponential growth in recent decades and the potential for these products to treat diverse, often rare, clinical indications is promising. The Office of Therapeutic Products (OTP) in the Center for Biologics Evaluation and Research (CBER) at the United States
Sandhya, Sanduja, Liz, Lessey-Morillon, Rondine, Allen, Xiaofei, Wang, Gavin, Imperato, Judith, Arcidiacono   +5 more
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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.
Deborah A, Wing, Barbara, Powers, Durlin, Hickok   +2 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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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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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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United States Food and Drug Administration’s Total Diet Study Program

2013
The 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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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.
Roger, Li, William B, Tabayoyong, Charles C, Guo, Graciela M Nogueras, González, Neema, Navai, H Barton, Grossman, Colin P, Dinney, Ashish M, Kamat   +7 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.
Consolacion Molto, Thomas J. Hwang, Marta Andres, Maria Borrell, Ignasi J. Gich Saladich, Agust Barnadas, Eitan Amir, Aaron S. Kesselheim, Ariadna Tibau Martorell   +8 more
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