Results 281 to 290 of about 787,943 (334)

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
openaire   +1 more source

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
openaire   +2 more sources

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
openaire   +2 more sources

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.
openaire   +1 more source

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.
openaire   +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.
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
openaire   +2 more sources

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
openaire   +1 more source

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).
Chinmay Shukla, Jing Li, Robert Lionberger, Edward D. Bashaw   +3 more
openaire   +1 more source

Comparing Generic and Innovator Drugs: A Review of 12 Years of Bioequivalence Data from the United States Food and Drug Administration

The Annals of Pharmacotherapy, 2009
B. Davit, P. Nwakama, Gary Buehler, D. Conner, S. Haidar, Dewrat T Patel, Yongsheng Yang, Lawrence X. Yu, J. Woodcock   +8 more
semanticscholar   +1 more source

Cancer Statistics, 2021

Ca-A Cancer Journal for Clinicians, 2021
Rebecca L Siegel, Kimberly D Miller
exaly