Results 361 to 370 of about 1,448,909 (408)

Food and Drug Administration Regulation

CNS Spectrums, 2008
As disease-modifying therapies near realization, there are concerns about the criteria by which these therapies will be judged. It is not yet clear what kind of evidence (clinical, biomarker, or otherwise) will be required to support a disease-modifying claim.
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The U.S. Food and Drug Administration's Experience with Ivacaftor in Cystic Fibrosis. Establishing Efficacy Using In Vitro Data in Lieu of a Clinical Trial.

Annals of the American Thoracic Society, 2018
On May 17, 2017, the U.S. Food and Drug Administration expanded the patient population for use of ivacaftor to include patients with cystic fibrosis with relatively rare mutations in the cystic fibrosis transmembrane conductance regulator gene. The label
A. Durmowicz, R. Lim, Hobart L Rogers, C. Rosebraugh, B. Chowdhury   +4 more
semanticscholar   +1 more source

The Food and Drug Administration Modernization Act and the Food and Drug Administration: Metamorphosis or Makeover?

Drug Information Journal, 2000
The Food and Drug Administration Modernization Act of 1997 (FDAMA) is the first legislation to bring about significant and widespread modifications to the regulatory environment for drugs and biologicals in more than 35 years. The expectations of what FDAMA is to accomplish are high.
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A Need for Reorganization of the Food and Drug Administration

Journal of Environmental Pathology, Toxicology and Oncology, 2010
The associate director for science and medicine in the Office of Drug Safety at the Food and Drug Administration (FDA), Dr. David Graham, reported that the FDA was incapable of protecting Americans from unsafe drugs. In testimony to the Senate Finance Committee, he stated that the FDA has let the American people down and betrayed public trust.
William B. Long, Jill S. Reddig, K. Dean Gubler, Shelley S. Mason, Richard F. Edlich   +4 more
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The Food and Drug Administration Challenger

2021
The Food and Drug Administration must go. This organization is costly, is a gargantuan waste of time and causes needless deaths by slowing down innovation. The sooner it is disbanded, the better.
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Blueprint for a Stronger Food and Drug Administration

New England Journal of Medicine, 2006
Over the past 5 years, a series of recalls of high-profile prescription medications has aroused serious concern about the safety of the nation's drug supply. Faced with a crisis of confidence, the Food and Drug Administration (FDA) in 2004 called on the Institute of Medicine (IOM) of the National Academies to conduct a comprehensive review of the ...
Stephen Morrissey, Jeffrey M. Drazen, Gregory D. Curfman   +2 more
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Impact of Food and Drug Administration Approval of Vismodegib on Prevalence of Orbital Exenteration as a Necessary Surgical Treatment for Locally Advanced Periocular Basal Cell Carcinoma.

Ophthalmic Plastic and Reconstructive Surgery, 2019
PURPOSE To test the hypothesis that the US Food and Drug Administration approval of vismodegib in early 2012 has reduced the prevalence of orbital exenteration for locally advanced periocular basal cell carcinoma (BCC).
O. Sagiv, S. Ding, R. Ferrarotto, B. Glisson, M. Altan, F. Johnson, Y. Elamin, S. Thakar, P. Nagarajan, B. Esmaeli   +9 more
semanticscholar   +1 more source

The Role of the Food and Drug Administration in Ophthalmology

Archives of Ophthalmology, 1986
Since 1976, the Food and Drug Administration (FDA) has been increasingly involved in the regulation of medical devices, much as it has been involved for decades in the regulation of drugs. For the ophthalmic profession and industry, this regulatory role of the FDA that requires documentation of safety and effectiveness has often appeared as both ...
John W. Chandler, Scott MacRae, David M. Worthen, Walter J. Stark, Claude L. Cowan   +4 more
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Making Sense of Stem Cells and Fat Grafting in Plastic Surgery: The Hype, Evidence, and Evolving U.S. Food and Drug Administration Regulations

Plastic and Reconstructive Surgery, 2019
Summary: Autologous fat grafting and adipose-derived stem cells are two distinct entities with two different risk profiles, and should be regulated as such.
Rod J. Rohrich, Dinah Wan
semanticscholar   +1 more source

United States food and drug administration

Clinical Engineering Handbook, 2020
C. Carey
semanticscholar   +1 more source