Results 271 to 280 of about 249,531 (314)

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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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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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).
Chinmay Shukla, Jing Li, Robert Lionberger, Edward D. Bashaw   +3 more
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The United States Food and Drug Administration and the practice of optometry.

Journal of the American Optometric Association, 1979
In the past decade the United States Food and Drug Administration has become increasingly involved with the regulation of materials used in the practice of optometry. It is the purpose of this paper to help the practitioner understand the FDA involvement, historically and legally, organization, how one can have input into the process, the procedures ...
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Nonclinical Development of Radiopharmaceuticals: Regulatory Considerations for the United States Food and Drug Administration

2004
In general, the nonclinical studies conducted to support the development of radiopharmaceuticals should be consistent with current International Conference on Harmonization (ICH) Guidelines. The United States Food and Drug Administration (FDA), however, has recognized that certain characteristics of radiopharmaceuticals necessitate an adaptation of the
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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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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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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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Outpatient Fluoroquinolone Prescription Fills in the United States, 2014 to 2020: Assessing the Impact of Food and Drug Administration Safety Warnings

Antimicrobial Agents and Chemotherapy, 2021
Deanna J Buehrle, Marilyn M Wagener
exaly