Materials for use in formulating combination products - Presentation @ ExcipientFest Americas 2017

ABSTRACT: How are atypical actives being managed and regulated by FDA? Overview of activities from the Atypical Actives Coalition, an industry group created to define reasonable requirements and controls which establish regulatory flexibility by FDA, EMA and other global agencies for the use of certain excipients used as atypical actives in drug products. The coalition seeks use of appropriate GMPs based on risk rather than full ICH Q7 API GMP compliance.

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