The FDA has recently published a draft guidance entitled “Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators: Guidance for Industry”, which offers an alternative to benefit non-commercial individual investigators who prepare and submit an IND. This guidance offers sponsor-investigator with step-by-step information for INDs. “For example, protocols for Phase II and III studies should cover all aspects of the trial, including the number of subjects, inclusion and exclusion criteria, investigational methods and control groups, how the dose was determined and which procedures or tests will be used to measure the drug’s effect.”
To check out FDA’s new guidance go to: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM446695.pdf
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