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"Innovation or Stagnation? Challenge
and Opportunity on the Critical Path to New Medical Products"
FDA issued this major report identifying both the problems and potential solutions
to the daunting task of ensuring that the unprecedented breakthroughs in medical
science are demonstrated to be safe and effective for patients as quickly and
inexpensively as possible. Titled "Innovation or Stagnation? Challenge
and Opportunity on the Critical Path to New Medical Products," the report
carefully examines the "Critical Path" of medical product development
-- the crucial steps that determine whether and how quickly a medical discovery
becomes a reliable medical treatment for patients.
Inside Clinical Trials: Testing
Medical Products in People
From the September-October 2003 FDA Consumer magazine
Comparison of FDA and HHS Regulations
A chart comparing FDA's regulations for human subject protection with those
of the Department of Health and Human Services.
From Test Tube to Patient:
Improving Health Through Human Drugs
This FDA publication tells the story of new drug development in the United States.
Articles discuss various aspects of drug development--from test tube to medicine
cabinet. This is an excellent primer for learning about the drug development
and approval process.
If you do not have PowerPoint software, you can see the presentations using the free PowerPoint viewer.