Items Tagged with 'Guidances'


U.S. FDA to Revise QualitySystems Guidance Per ICH Q10

The U.S. Food and Drug Administration (FDA) will update its current good manufacturing practices (cGMPs) quality systems (QSs) guidance to conform to international pharmaceutical QS guidelines, the agency said March 23 at a Drug Information Association conference.

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FDA Issues New Guidance for Laser Product Labeling

CDRH will, under some circumstances, allow laser product manufacturers to use alternate means to provide the required certification, identification and warning labeling without applying for or receiving approval, according to a recent guidance.

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