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Potential consumer response to the healthy symbol proposed by the U.S. food and Drug Administration. [PDF]
Hyink J, McFadden BR, Ellison B.
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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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