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Animal & Veterinary

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Withdrawn / Replaced

Withdrawn/Replaced Guidances

 

No. Title Date
     
1 Anticoccidial Guidelines  Replaced by Guideline 40
2 Anthelmintics   Withdrawn 12/22/2004
4 Guidelines for Efficacy Studies for Systemic Sustained Release Sulfonamide Boluses for Cattle  Withdrawn 12/22/2004
8 Guidelines for Toxicological Investigations 
 		 Replaced by Guideline 3
9 Preclearance Guidelines for Production Drugs 
  		  Withdrawn pending revisions
10  Amendment of Section II(G)(1)(b)(4) of the Preclearance Guidelines  Withdrawn pending revisions
14 Guideline and Format for Reporting the Details of Clinical Trials Using An Investigational New Animal Drug in Food Producing Animals   Withdrawn 12/22/2004
15 Guideline and Format for Reporting the Details of Clinical Trials Using An Investigational New Animal Drug in Non-Food Producing Animals    Withdrawn 12/22/2004
16 FOI Summary Guideline Withdrawn  02/24/2005
17 Working Guidelines for Assigning Residue Tolerances  Replaced by Guideline 3
18  Antibacterial Drugs in Animal Feeds: Human Health Safety Criteria    Withdrawn 12/22/2004
19 Antibacterial Drugs in Animal Feeds: Animal Health Safety Criteria    Withdrawn 12/22/2004
20 Antibacterial Drugs in Animal Feeds: Antibacterial Effectiveness Criteria   Withdrawn 12/22/2004
21 Nutritional Ingredients in Animal Drugs and Feeds

Replaced by P&P 1240.3420

 9/17/09
25 Guidelines for the Efficacy Evaluation of Equine Anthelmintics   Replaced by Guidance 109
26 Guidelines for the Preparation of Data to Satisfy the Requirements of Section 512 of the Act Regarding Animal Safety, Effectiveness, Human Food Safety and Environmental Considerations for Minor Use of New Animal Drugs   04/86 (superceded by Guidance 61) Repl
27 New Animal Drug Determinations

Replaced by P&P 1240.3500

9/17/09
28 Animal Drug Applications Expedited Review Guideline Replaced by P&P 1240.3135 10/14/09
29 Guidelines for the Effectiveness Evaluation of Swine Anthelmintics   Replaced by Guidance 110
30 Guidelines for Anti-infective Bovine Mastitis Product Development   Replaced by Guideline 49
31 Guideline for the Evaluation of Bovine Anthelmintics   Replaced by Guideline 95
32 Guideline for Threshold Assessment   Replaced by Guideline  3
33 Target Animal Safety Guidelines for New Animal Drugs  Replaced by #185 4/24/09
34 Biomass Guideline - Guideline for New Animal Drugs and Food Additives Derived From a Fermentation; Human Food Safety Evaluation  Replaced by Guideline  3
36 Guidelines for Efficacy Evaluation of Canine/Feline Anthelmintics    Replaced by Guidance  111
39 Guideline on the Conduct of Clinical Investigations: Responsibilities of Clinical Investigators and Monitors for Investigational New Animal Drug Studies   Replaced by Guidance 85
41 Draft Guideline:  Formatting, Assembling, and Submitting New Animal Drug Applications    Withdrawn 3/2002
43 Draft Guideline for Generic Animal Drug Products Containing Fermentation-Derived Drug Substances   Withdrawn 05/24/06
51 Points to Consider Guideline - Development of a Pharmacokinetic Guideline Enabling Flexible Labeling of Therapeutic Antimicrobials  See Guidance 66 for updated information
52 Assessment of the Effects of Antimicrobial Drug Residues from Food of Animal Origin on the Human Intestinal Flora, February 18, 2004   Replaced by Guidance 159
54 Draft Guideline for Utility Studies for Anti-Salmonella Chemical Food Additives in Animal Feeds   06/94 --See Final Guidance 80
58 Guidance for Industry for Good Target Animal Study Practices: Clinical Investigators and Monitors  Withdrawn 12/22/2004; superseded by guidance 85
60 Guidance For Industry: Animal Proteins Prohibited From Animal Feed; Small Entity Compliance Guide Replaced by Guidance 67, 68, 69, and 70
66 Withdrawal of Guidance Document on Professional Flexible Labeling of Antimicrobial Drugs  Withdrawn 01/30/2002
77 Guidance for Industry: Interpretation of On-Farm Feed Manufacturing and Mixing Operations: DRAFT GUIDANCE Withdrawn 06/12/03
78 Consideration of the Human Health Impact of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing Animals Replaced by Guidance 152
154 Draft Guidance for Industry: 21 CFR Part 11; Electronic Records; Electronic Signatures, Maintenance of Electronic Records Withdrawn 02/25/03 Withdrawn 02/25/03
155  Draft Guidance for Industry: 21 CFR Part 11: Electronic Records; Electronic Signatures; Electronic Copies of Electronic Records Withdrawn 02/4/03
172  Guidance for Industry #172 - Use of unapproved hormone implants in veal calves, April 2, 2004   Withdrawn 07/15/04

 

 

    
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