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Center For Veterinary Medicine U S
1
E-Books/E-Docs
 

Annual report


Center for Veterinary Medicine (U.S.)
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, [2003]- 2003

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 Axe Federal Documents Online  HE 20.4401:    ---  Available
2
E-Books/E-Docs
 

FDA approved animal drug products



[Rockville, MD] : US Dept. of Health and Human Resources [i.e. Services], Food and Drug Administration, Center for Veterinary Medicine 2008

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 Axe Federal Documents Online  HE 20.4411:    ---  Available
3
E-Books/E-Docs
 

FY ... performance report to the Congress for the Animal Drug User Fee Act


Center for Veterinary Medicine (U.S.)
Rockville, MD : Dept. of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine 2004

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 Axe Federal Documents Online  HE 20.4401/2:    ---  Available
4
E-Books/E-Docs
 

Guidance for industry



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, [2002] 2002

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 Axe Federal Documents Online  HE 20.4402:AN 8/7    ---  Available
5
E-Books/E-Docs
 

Guidance for industry 21 CFR, part 11, electronic records : electronic signatures, electronic copies



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Regulatory Affairs : Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Devices and Radiological Health : Center for Food Safety and Applied Nutrition : Center for Veterinary Medicine, [2002] 2002

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Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4002:EL 2/3    ---  Available
6
E-Books/E-Docs
 

Guidance for industry 21 CFR part 11, electronic records, electronic signatures, validation.



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Regulatory Affairs : Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Devices and Radiological Health : Center for Food Safety and Applied Nutrition : Center for Veterinary Medicine, [2001] 2001

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Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4702:EL 2/4    ---  Available
7
E-Books/E-Docs
 

Guidance for industry bioanalytical method validation.



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Veterinary Medicine, [2001] 2001

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Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4702:B 52/4    ---  Available
8
E-Books/E-Docs
 

Guidance for industry comparability protocols, protein drug products and biological products; chemis



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Veterinary Medicine, [2003] 2003

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Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4802:P 94/2    ---  Available
9
E-Books/E-Docs
 

Guidance for industry computerized systems used in clinical trials.



[Rockville, MD] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Devices and Radiological Health : Center for Food Safety and Nutrition : Center for Veterinary Medicine : Office of Regulatory Affairs, [1999] 1999

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Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4802:C 73/2    ---  Available
10
E-Books/E-Docs
 

Guidance for industry consumer-directed broadcast advertisements.



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration : Center for Biologics Evaluation and Research : Center for Veterinary Medicine, [1999] 1999

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 Axe Federal Documents Online  HE 20.4702:B 78    ---  Available
11
E-Books/E-Docs
 

Guidance for industry consumer-directed broadcast advertisements, questions and answers.



[Rockville, Md.] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research : Center for Veterinary Medicine, [1999] 1999

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 Axe Federal Documents Online  HE 20.4702:B 78/2    ---  Available
12
E-Books/E-Docs
 

Guidance for industry container and closure system integrity testing in lieu of sterility testing as



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, Center for Veterinary Medicine, [2008] 2008

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Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4802:C 76    ---  Available
13
E-Books/E-Docs
 

Guidance for industry effectiveness of anthelmintics, general recommendations.



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine 2001

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Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4402:AN 8    ---  Available
14
E-Books/E-Docs
 

Guidance for industry effectiveness of anthelmintics, specific recommendations for bovines.



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, [2001] 2001

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Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4402:AN 8/2    ---  Available
15
E-Books/E-Docs
 

Guidance for industry effectiveness of anthelmintics, specific recommendations for caprine.



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, [2001] 2001

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 Axe Federal Documents Online  HE 20.4402:AN 8/4    ---  Available
16
E-Books/E-Docs
 

Guidance for industry effectiveness of anthelmintics, specific recommendations for equine.



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, [2002] 2002

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Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4402:AN 8/5    ---  Available
17
E-Books/E-Docs
 

Guidance for industry effectiveness of anthelmintics, specific recommendations for feline.



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, [2002] 2002

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Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4402:AN 8/8    ---  Available
18
E-Books/E-Docs
 

Guidance for industry effectiveness of anthelmintics, specific recommendations for ovine.



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, [2001] 2001

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 Axe Federal Documents Online  HE 20.4402:AN 8/3    ---  Available
19
E-Books/E-Docs
 

Guidance for industry effectiveness of anthelmintics, specific recommendations for porcine.



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, [2002] 2002

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 Axe Federal Documents Online  HE 20.4402:AN 8/6    ---  Available
20
E-Books/E-Docs
 

Guidance for industry effectiveness of anthelmintics, specific recommendations for poultry-gallus ga



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, [2002] 2002

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Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4402:AN 8/9    ---  Available
21
E-Books/E-Docs
 

Guidance for industry environmental impact assessments (EIA's) for veterinary medicinal products (VM



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, [2001] 2001

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Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4402:EN 8    ---  Available
22
E-Books/E-Docs
 

Guidance for industry FDA export certificates.



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Devices and Radiological Health : Center for Veterinary Medicine : Center for Food Safety and Applied Nutrition, [2005] 2005

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Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4802:F 73    ---  Available
23
E-Books/E-Docs
 

Guidance for industry formal dispute resolution : scientific and technical issues related to pharmac



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2006] 2006

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Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4702:D 63    ---  Available
24
E-Books/E-Docs
 

Guidance for industry impurities in new veterinary drug substances (revision).



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, [2007] 2007

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 Axe Federal Documents Online  HE 20.4402:IM 7    ---  Available
25
E-Books/E-Docs
 

Guidance for industry impurities, residual solvents in new veterinary medicinal products, active sub



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, [2001] 2001

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 Axe Federal Documents Online  HE 20.4402:IM 7/2    ---  Available
26
E-Books/E-Docs
 

Guidance for industry manufacturing, processing, or holding active pharmaceutical ingredients.



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [1998] 1998

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 Axe Federal Documents Online  HE 20.4702:P 49/7    ---  Available
27
E-Books/E-Docs
 

Guidance for industry part 11, electronic records : electronic signatures--scope and application.



[Rockville, MD] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research : Center for Devices and Radiological Health : Center for Food Safety and Applied Nutrition : Center for Veterinary Medicine : Office of Regulatory Affairs, [2003] 2003

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Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4702:EL 2/3    ---  Available
28
E-Books/E-Docs
 

Guidance for industry PAT, a framework for innovative pharmaceutical development, manufacturing, and



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2004] 2004

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Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4702:P 49/6    ---  Available
29
E-Books/E-Docs
 

Guidance for industry pharmaceutical components at risk for melamine contamination.



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Veterinary Medicine, [2009] 2009

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 Axe Federal Documents Online  HE 20.4702:P 49/8    ---  Available
30
E-Books/E-Docs
 

Guidance for industry pharmacovigilance of veterinary medicinal products, management of adverse even



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, [2006] 2006

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Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4402:P 49    ---  Available
31
E-Books/E-Docs
 

Guidance for industry pharmacovigilance of veterinary medicinal products : management of periodical



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, [2001] 2001

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 Axe Federal Documents Online  HE 20.4402:P 49/2    ---  Available
32
E-Books/E-Docs
 

Guidance for industry pre-approval information for registration of new veterinary medicinal products



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, [2004] 2004

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 Axe Federal Documents Online  HE 20.4402:P 91/2    ---  Available
33
E-Books/E-Docs
 

Guidance for industry presenting risk information in prescription drug and medical device promotion.



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2009] 2009

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 Axe Federal Documents Online  HE 20.4702:R 49/5/DRAFT    ---  Available
34
E-Books/E-Docs
 

Guidance for industry process validation, general principles and practices.



Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) ; Rockville, MD : Center for Biologics Evaluation and Research (CBER) : Center for Veterinary Medicine (CGMP), [2008] 2008

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 Axe Federal Documents Online  HE 20.4802:P 49/6    ---  Available
35
E-Books/E-Docs
 

Guidance for industry providing regulatory submissions in electronic format, general considerations.



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Devices and Radiological Health : Center for Food Safety and Applied Nutrition : Center for Veterinary Medicine, [2003] 2003

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Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4802:R 26/5/DRAFT    ---  Available
36
E-Books/E-Docs
 

Guidance for industry quality systems approach to pharmaceutical CGMP regulations.



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2006] 2006

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Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4702:Q 1/2    ---  Available
37
E-Books/E-Docs
 

Guidance for industry safety studies for veterinary drug residues in human food, reproduction toxici



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, [2006] 2006

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Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4402:SA 1    ---  Available
38
E-Books/E-Docs
 

Guidance for industry stability testing for medicated premixes.



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, [2000] 2000

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Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4402:P 91    ---  Available
39
E-Books/E-Docs
 

Guidance for industry stability testing of new biotechnological/biological veterinary medicinal prod



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, [2001] 2001

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Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4402:ST 1/4    ---  Available
40
E-Books/E-Docs
 

Guidance for industry stability testing of new veterinary dosage forms.



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, [1999] 1999

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Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4402:ST 1/2    ---  Available
41
E-Books/E-Docs
 

Guidance for industry stability testing of new veterinary drug substances and medicinal products (re



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Veterinary Mediicine, [2007] 1999

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Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4402:ST 1    ---  Available
42
E-Books/E-Docs
 

Guidance for industry stability testing, photostability testing of new veterinary drug substances an



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Verterinary Medicine, [1999] 1999

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Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4402:ST 1/3    ---  Available
43
E-Books/E-Docs
 

Guidance for industry studies to evaluate the safety of residues of veterinary drugs in human food,



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, [2006] 2006

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Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4402:SA 1/3    ---  Available
44
E-Books/E-Docs
 

Guidance for industry studies to evaluate the safety of residues of veterinary drugs in human food,



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, [2006] 2006

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Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4402:SA 1/2    ---  Available
45
E-Books/E-Docs
 

Guidance for industry submission of documentation in applications for parametric release of human an



Silver, Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research ; Rockville, MD : Center for Veterinary Medicine : Center for Biologics Evaluation and Research, [2008] 2008

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Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4802:P 21    ---  Available
46
E-Books/E-Docs
 

Guidance for industry submission of documentation in applications for parametric release of human an



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2010] 2010

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 Axe Federal Documents Online  HE 20.4702:P 21    ---  Available
47
E-Books/E-Docs
 

Guidance for industry for the submission documentation for sterilization process validation in appli



[Rockville, MD] : Center for Drug Evaluation and Research : Center for Veterinary Medicine, [1994] 1994

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 Axe Federal Documents Online  HE 20.4702:ST 4/2    ---  Available
48
E-Books/E-Docs
 

Guidance for industry. electronic signatures, scope and application.



Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2003] 2003

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Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4702:EL 2/5    ---  Available
49
E-Books/E-Docs
 

The judicious use of antimicrobials for dairy producers



[Rockville, Md.] : Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Veterinary Medicine, [2002] 2002

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Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4002:2002023862    ---  Available
50
E-Books/E-Docs
 

Performance report to Congress for the Animal Drug User Fee Act


Center for Veterinary Medicine (U.S.)
Rockville, MD : Food and Drug Administration, Center for Veterinary Medicine, 2005- 2005

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Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4401/2:    ---  Available
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