Guidance for Industry

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CVM develops and issues its guidance documents in accordance with FDA's good guidance practices regulations (21 CFR 10.115) published in the Federal Register on September 19, 2000 (65 FR 5646). 

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GUIDANCE BY SUBJECT

Adverse Event Reporting	Food Additives
Advertising And Promotion	Generics
Aquaculture	Human Food Safety
Antimicrobial Resistance	INAD
Anthelmintics	Labeling
Biotechnology	MUMS
Bovine Spongiform Encephalopathy (BSE)	New Animal Drug Application
Chemistry Manufacturing and Controls	Procedural
Compliance Policy Guides	Small Entity Compliance Guides
Current Good Manufacture Practices	Target Animal- Effectiveness
Electronic Submissions	Target Animal- Safety
Environmental Safety	User Fees- ADUFA/AGDUFA
Feed/Food	VICH