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GUIDANCE DOCUMENT

Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP January 2006

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2003-D-0369
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine
Office of Regulatory Affairs
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

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.

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2003-D-0369.

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