About the Investigations
The bulk of OC's inspections involve investigators who conduct clinical research. Inspections are conducted by FDA's Office of Regulatory Affairs (ORA). OC issues assignments to ORA personnel. If a particular medical or scientific expertise is needed that the ORA inspection team does not have, OC personnel will participate.
Results of the inspections are evaluated from a scientific and regulatory perspective. OC recommends whether scientific data are acceptable in support of a new drug application. After an inspection, a determination is made about what course of regulatory action needs to be taken. OC conducts outreach, interacts with stakeholders, clinical researchers and sponsors, and offers guidance on good clinical practices.
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