Control of Pharmaceutical Production; Out-of-Specification Guidance for Laboratory Testing; Notice of Public Meeting

摘要

The Food and Drug Administration (FDA) is announcing a public meeting sponsored by the Office of Regulatory Affairs (ORA), FDA. This meeting will involve representatives from ORA's Division of Field Science, the Center for Drug Evaluation and Research, and other representatives from FDA. The topic of this public meeting is out-of- specification (OOS) laboratory test results used in pharmaceutical production. This meeting will provide guidance in appropriate evaluation of, and response to, out-of-specification test results.