FDA Resource Manual for Clinical Investigations: Regulations, Guidelines, and Other References for Conducting Clinical Trials under Investigational New Drug Applications

摘要

The Food and Drug Administration assembled these regulations, guidelines, and other FDA references for a pilot workshop that FDA sponsored for community-based research groups that were conducting or would soon be conducting clinical trials of therapies for the spectrum of HIV infection. None of these references were developed specifically for the pilot workshop. However, the FDA believes they contain essential information for the conduct of studies that would produce reliable and accurate data that could support the approval of not only therapies for HIV infection but for other therapies in general. Even though the manual was assembled in response to the immediate need identified by community-based physicians for HIV therapies, the regulations are applicable for all studies that are being conducted under an investigational new drug application.