Category Archive: Documents, PHT US
... Drugs transitioning from OTC to VFD status
Jan 05, 2017PHT EditorComments Off on Drugs transitioning from OTC to VFD status
A list of over-the-counter drugs that will require a VFD as of January 1, 2017 is provided in this document.... Guidance for Industry #233: Veterinary Feed Directive Common Format Questions and Answers
Sep 26, 2016PHT EditorComments Off on Guidance for Industry #233: Veterinary Feed Directive Common Format Questions and Answers
This document provides examples that illustrate how a common VFD format might appear and how some of the information on the VFD may be pre-populated by an animal health company.... FDA Fact Sheet: Veterinary Feed Directive final rule and next steps
Apr 22, 2016PHT EditorComments Off on FDA Fact Sheet: Veterinary Feed Directive final rule and next steps
The VFD final rule outlines the process for authorizing use of VFD drugs (animal drugs intended for use in or on animal feed that require the supervision of a licensed veterinarian) and provides...... Veterinary Feed Directive, Final Rule
Mar 24, 2016PHT EditorComments Off on Veterinary Feed Directive, Final Rule
Amendment to FDA's animal drug regulations regarding VFD drugs, which is intended to improve the efficiency of the VFD program while protecting human and animal health.... Guidance for Industry No 120
Mar 08, 2016PHT EditorComments Off on Guidance for Industry No 120
Small entity compliance guide, and questions and answers regarding veterinary feed directive regulations.... Guidance for Industry No 233
Mar 07, 2016PHT EditorComments Off on Guidance for Industry No 233
Common questions and answers regarding veterinary feed directive regulations.... Guidance for Industry No 209
Mar 07, 2016PHT EditorComments Off on Guidance for Industry No 209
Recommendations for the judicious use of medically important antimicrobial drugs in food-producing animals.... Guidance for Industry No 152
Mar 07, 2016PHT EditorComments Off on Guidance for Industry No 152
Recommendations for assessing the safety of antimicrobial new animal drugs with regard to their microbiological effects on bacteria of human health concern.... Free 2015 AAAP Proceedings Booklet
Jan 21, 2016PHT EditorComments Off on Free 2015 AAAP Proceedings Booklet
Pressures to reduce or eliminate antibiotics from poultry production have created new health and welfare challenges for chickens and turkeys. In this lively roundtable discussion, poultry industry...... #152 Guidance for Industry: Evaluating the safety of antimicrobial new animal drugs with regard to their microbiological effects on bacteria of human health concern
Jul 03, 2014wpengineComments Off on #152 Guidance for Industry: Evaluating the safety of antimicrobial new animal drugs with regard to their microbiological effects on bacteria of human health concern
Appendix A of this document ranks antimicrobial drugs according to their importance in human medicine and may be updated by FDA.... Antibiotic resistance threats in the United States, 2013
Jan 22, 2014wpengineComments Off on Antibiotic resistance threats in the United States, 2013
This CDC report explores antimicrobial resistance, one of our most serious health threats. Efforts to prevent such threats build on the foundation of proven public health strategies: immunization,...... #209 Guidance for Industry: The judicious use of medically important antimicrobial drugs in food-producing animals.
Jan 15, 2014wpengineComments Off on #209 Guidance for Industry: The judicious use of medically important antimicrobial drugs in food-producing animals.
GFI 209 presents the FDA’s recent thinking on the topic and lays out FDA strategy and recommendations.... Guidance for Industry No 213
Jan 05, 2014wpengineComments Off on Guidance for Industry No 213
Provides recommendations and voluntary timelines to voluntarily implement the judicious use of antibiotics in ways that address public health concerns while maintaining the health, performance and...