Welcome to the Kids' Library!

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

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

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

Guidance for industry

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

A review of FDA's implementation of the Drug Export Amendments of 1986

Rockville, MD : U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Biologics Evaluation and Research, [1990] 1990