GUIDANCE DOCUMENT

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

Final

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

This document is intended to provide guidance to manufacturers of veterinary and human drugs, including human biological drug products, on how to resolve disputes of scientific and technical issues relating to current good manufacturing practice (CGMP) requirements. This document is not intended to cover medical devices regulated by the Center for Devices and Radiological Health (CDRH) or foods or dietary supplements regulated by the Center for Food Safety and Applied Nutrition (CFSAN).

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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 comments should be identified with the title of the guidance.