Results 261 to 270 of about 249,531 (314)

An Overview of the United States Food and Drug Administration

Marina Hahn
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Analysis of adverse events with sclerosants reported to the United States Food and Drug Administration

Phlebology: The Journal of Venous Disease, 2022
Objectives To analyze adverse events (AEs) related to sclerosants reported through the Federal Adverse Event Reporting System (FAERS). Methods We queried the FAERS database for all cases associated with sclerosants.
Christopher N Nguyen, Quoc-Bao D Nguyen, Sirunya Silapunt   +2 more
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United States Food and Drug Administration Drug Approval Summary

Clinical Cancer Research, 2004
Abstract On May 5, 2003, gefitinib (Iressa; ZD1839) 250-mg tablets (AstraZeneca Inc.) received accelerated approval by the United States Food and Drug Administration as monotherapy for patients with locally advanced or metastatic non-small cell lung cancer after failure of both platinum-based and docetaxel chemotherapies.
Martin H. Cohen, Grant A. Williams, Rajeshwari Sridhara, Gang Chen, W. David McGuinn, David Morse, Sophia Abraham, Atiqur Rahman, Chenyi Liang, Richard Lostritto, Amy Baird, Richard Pazdur   +11 more
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End Points and United States Food and Drug Administration Approval of Oncology Drugs

Journal of Clinical Oncology, 2003
Purpose: To summarize the end points used by the United States Food and Drug Administration (FDA) to approve new cancer drug applications over the last 13 years. Materials and Methods: The FDA granted marketing approval to 71 oncology drug applications between January 1, 1990, and November 1, 2002.
John R, Johnson, Grant, Williams, Richard, Pazdur   +2 more
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Results of the United States Food and Drug Administration Clinical Trial of the CustomFlex Artificial Iris

Ophthalmology, 2022
To evaluate safety and efficacy of a custom-manufactured artificial iris device (CustomFlex Artificial Iris; HumanOptics AG) for the treatment of congenital and acquired iris defects.Multicenter, prospective, unmasked, nonrandomized, interventional clinical trial.Patients with photophobia, sensitivity secondary to partial or complete congenital or ...
Brandon D. Ayres, Barbara S. Fant, Zachary C. Landis, Kevin M. Miller, R. Doyle Stulting, Robert J. Cionni, Nicole R. Fram, Stephen Hamilton, David R. Hardten, Douglas D. Koch, Samuel Masket, Francis W. Price, Kenneth J. Rosenthal, M. Bowes Hamill, Michael E. Snyder   +14 more
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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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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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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 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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