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Imprese · 30/05/19971 min di lettura
Control of Pharmaceutical Production; Out-of-Specification Guidance for Laboratory Testing; Notice of Public Meeting
Traduzione automatica locale · Lingua originale della fonte
Riepilogo
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.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →