Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP

Issue Date: January 11, 2006
Issued by: Center for Veterinary Medicine
Topic(s): Investigation & Enforcement, Current Good Manufacturing Practice (CGMP), Pharmaceutical Quality
Status: Final

Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled “Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP.” The guidance describes a formal, two-tiered dispute resolution process intended to resolve disputes of scientific and technical issues relating to current good manufacturing practice (CGMP) that arise during FDA inspections of pharmaceutical manufacturers.

Download the Guidance Document

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Avance Biosciences is a leading Contract Research Organization (CRO) and Contract Testing Organization (CTO) providing CGMP and GLP-compliant analytical and bioanalytical services to support drug development. From early discovery through clinical development and commercialization, we provide CGMP and GLP-compliant services tailored to your therapeutic modality and regulatory needs.