Results 261 to 270 of about 578,726 (316)
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Transparency at the Food and Drug Administration
New England Journal of Medicine, 2010The FDA recently released a report from its Transparency Task Force containing 21 draft proposals for expanding the disclosure of information by the agency while maintaining confidentiality for trade secrets and individually identifiable patient information. Afia Asamoah and Dr. Joshua Sharfstein from the FDA discuss the transparency initiative.
Afia K. Asamoah, Joshua M. Sharfstein
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Drug Development, Guidelines, and the Food and Drug Administration
Annals of Internal Medicine, 1984Excerpt The costs of arthritis to society are climbing to an estimated $13.5 billion per year (1).
Allen H. Mackenzie, Sanford H. Roth
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Food and Drug Administration Regulation
CNS Spectrums, 2008As 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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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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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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Blueprint for a Stronger Food and Drug Administration
New England Journal of Medicine, 2006Over 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 +2 more
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The Food and Drug Administration Challenger
2021The 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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A Need for Reorganization of the Food and Drug Administration
Journal of Environmental Pathology, Toxicology and Oncology, 2010The 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 +4 more
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The Role of the Food and Drug Administration in Ophthalmology
Archives of Ophthalmology, 1986Since 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 +4 more
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Food and drug administration's requirements for markers
Controlled Clinical Trials, 1984Three basic principles must be satisfied when a substance is being considered for human ingestion: The composition of the product must be consistent within certain limits over a specific period of time. It must not produce irreversible harm or unacceptable side effects.
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Perspective of the Food and Drug Administration
1990While this chapter is primarily concerned with describing the perspective of the Food and Drug Administration (FDA) about what constitutes appropriate controlled trials of drugs in patients with epilepsy, it is impossible to fully understand the Agency’s viewpoint without some understanding of the legal and regulatory foundation of the Agency’s ...
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