Results 241 to 250 of about 551,808 (299)
Use and Public Reporting of Predetermined Change Control Plans for AI-Enabled Medical Devices.
JAMA Health ForumDabek PA +4 more
europepmc +1 more source
Some of the next articles are maybe not open access.
Related searches:
Related searches:
New England Journal of Medicine, 2015
The FDA has recommended a pathway to expedite completion of studies to ensure that new sunscreen ingredients are safe and effective. A renewed commitment to collaboration on high-quality studies could lead to breakthroughs in melanoma prevention.
Robert M Califf, Califf Robert M
exaly +3 more sources
The FDA has recommended a pathway to expedite completion of studies to ensure that new sunscreen ingredients are safe and effective. A renewed commitment to collaboration on high-quality studies could lead to breakthroughs in melanoma prevention.
Robert M Califf, Califf Robert M
exaly +3 more sources
IEEE Engineering in Medicine and Biology Magazine, 2006
This paper discusses the role of ethics in the Food and Drug Administration's approval process. The fundamental reasons for having a regulatory agency for food and medical products are ethical: concern for the safety and welfare of consumers. These basic ethical principles require a substantial number of regulations, guidances, procedures, and policies.
openaire +2 more sources
This paper discusses the role of ethics in the Food and Drug Administration's approval process. The fundamental reasons for having a regulatory agency for food and medical products are ethical: concern for the safety and welfare of consumers. These basic ethical principles require a substantial number of regulations, guidances, procedures, and policies.
openaire +2 more sources
European Journal of Preventive Cardiology, 2013
The Food and Drug Administration (FDA) relies upon adverse event data collected during pharmaceutical trials to evaluate the safety of medications, but these trials often fail to permit an adequate assessment of safety. The FDA usually recommends that at least 1500 patients be exposed to a new drug.
openaire +2 more sources
The Food and Drug Administration (FDA) relies upon adverse event data collected during pharmaceutical trials to evaluate the safety of medications, but these trials often fail to permit an adequate assessment of safety. The FDA usually recommends that at least 1500 patients be exposed to a new drug.
openaire +2 more sources
New England Journal of Medicine, 2005
In 1992, the passage of the Food and Drug Administration (FDA) Prescription Drug User Fee Act and, in 1997, the FDA Modernization Act resulted in an 85 percent increase in the number of employees at the FDA and in more efficient processes for the approval of drugs. In this article, the author identifies the remaining challenges facing the FDA.
openaire +2 more sources
In 1992, the passage of the Food and Drug Administration (FDA) Prescription Drug User Fee Act and, in 1997, the FDA Modernization Act resulted in an 85 percent increase in the number of employees at the FDA and in more efficient processes for the approval of drugs. In this article, the author identifies the remaining challenges facing the FDA.
openaire +2 more sources