Results 301 to 310 of about 1,330,290 (363)

Transparency at the Food and Drug Administration

New England Journal of Medicine, 2010
The 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
openaire   +3 more sources

Drug Development, Guidelines, and the Food and Drug Administration

Annals of Internal Medicine, 1984
Excerpt The costs of arthritis to society are climbing to an estimated $13.5 billion per year (1).
Allen H. Mackenzie, Sanford H. Roth
openaire   +3 more sources

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.
openaire   +3 more sources

Home - About - Disclaimer - Privacy