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COMPLIANCE POLICY GUIDE (CPG)

CPG Sec. 625.300 Unapproved New Animal Drugs - Follow-up Action to Approved Warning Letter - Direct Reference Seizure Authority March 1995

Final

CPG Sec. 625.300 Unapproved New Animal Drugs - Follow-up Action to Approved Warning Letter - Direct Reference Seizure Authority

Issued by:
Guidance Issuing Office
Center for Veterinary Medicine
Office of Regulatory Affairs

Criteria under which direct reference seizure of new animal drugs without approved New Animal Drug Applications, section 501(a)(5) cases, may be submitted by the appropriate division offices within the Office of Pharmaceutical Quality Operations (OPQO) directly to the OPQO Program Director and the Office of Enforcement.


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:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

Questions?

Contact Point
CVM
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Pl, HFV-1
Rockville, MD 20855
AskCVM@fda.hhs.gov
(240) 402-7002