Trial mobile version Guidances- combined files 6_27_14 - page 4

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DRUG RESEARCH AND INVESTIGATIONAL DRUGS
 FDA Information pages
These pages contain useful information for researchers and non-researchers alike on the drug
development process and the FDA Drug Review and Approval Process.
How Drugs are Developed and Approved
The FDA’s Drug Review Process
 U.S. Food and Drug Administration (FDA) Forms and Submission Requirements
This website is a listing of the various FDA forms and instructions, applicable to required
submissions to the FDA, in order to receive approval for various types of drug research.
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EDUCATIONAL REQUIREMENTS FOR NIH-FUNDED PROJECTS
 Human Subjects Research Education Requirements for NIH-funded Projects
The National Institutes of Health (NIH) has an ‘educational requirements’ policy for investigators
and key personnel on research projects that it funds. These frequently asked questions (FAQs)
explain the policy, how to comply with it, and how to document compliance.