Friday, January 31, 2014

Approved Animal Drug Products (Green Book)

Approved Animal Drug Products (Green Book)

FDA is extending the comment period for:

This information has recently been updated and is now available.

Update to Food Safety Modernization Act and Animal Feed – http://www.fda.gov/AnimalVeterinary/Products/AnimalFoodFeeds/ucm347941.htm
 
FDA is extending the comment period for:
 
 
 
Comments on this proposed rule and draft risk assessment as well as comments on the information collection provisions associated with these rules may be submitted until March 31, 2014. Comments were originally due by February 26, 2014.
 
 

CVM Updates FDA Seeking Public Input on Animal Drug User Fee Act Information Collection

CVM Updates FDA Seeking Public Input on Animal Drug User Fee Act Information Collection

Tuesday, January 28, 2014

The Law of Compounding Medications And Drugs: Drug critic slams FDA over antibiotic oversight in...

The Law of Compounding Medications And Drugs: Drug critic slams FDA over antibiotic oversight in...:   By P.J. Huffstutter and Brian Grow Mon Jan 27, 2014 11:40pm EST (Reuters) - The United States Food and Drug Administration allowed...

The Law of Compounding Medications And Drugs: FDA Found Drugs Used In Food Animals To Be 'High R...

The Law of Compounding Medications And Drugs: FDA Found Drugs Used In Food Animals To Be 'High R...: FDA Found Drugs Used In Food Animals To Be 'High Risk' by Dan Charles and Eliza Barclay January 28, 20...

Animal Food & Feeds Food Safety Modernization Act and Animal Feed

Animal Food & Feeds Food Safety Modernization Act and Animal Feed

The Law of Compounding Medications And Drugs: MUST READ!! Important! FDA Cites New Authorities ...

The Law of Compounding Medications And Drugs: MUST READ!! Important! FDA Cites New Authorities ...: By Alexander Gaffney, RAC Related Links Warning Letter to Triangle Pharmacy The issue of pharmaceutical compounding may have domi...

Equine Drugs and Medication Part 2

Equine Drugs and Medication Part 2

Wednesday, January 22, 2014

DA CVM Guidances Under Development for 2014

Guidances Under Development for 2014

CVM Guidance Documents Under Development
(expected to publish as drafts or finals by the end of December 2014)
Introduction
The following list of guidance topics includes possible new topics for guidance documents or revisions to existing guidance documents that the CVM is considering. We currently intend to develop guidance on each topic; however, the Center is neither bound by this list of topics, nor required to issue every guidance document on this list. We are not precluded from developing guidance documents on topics not on this list.
CVM Guidance Documents Under Development list has been updated to include those documents expected to publish by the end of 2014. FDA also publishes an agency-wide Annual Guidance Agenda which includes CVM's Guidance Documents Under Development and is available for public comment.
Center for Veterinary Medicine
2014 Guidance Agenda

Title of GuidanceContact
Guidance For Industry (GFI #79) – Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine (Revision)Marcia Larkins, Center for Veterinary Medicine, Food and Drug Administration, (HFV-1), 7519 Standish Place, Rockville, MD 20855, 240-276-9015, Email: marcia.larkins@fda.hhs.gov
Draft Guidance for Industry – Marketed Unapproved New Animal DrugsNadine Steinberg, Center for Veterinary Medicine, Food and Drug Administration, (HFV-1), 7519 Standish Place, Rockville, MD 20855, 240-276-8849, nadine.steinberg@fda.hhs.gov
Guidance For Industry (GFI #61) - FDA Approval of Animal Drugs for Minor Uses and for Minor Species (Revision)Margaret Oeller, Center for Veterinary Medicine (HFV-50), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0566, margaret.oeller@fda.hhs.gov
Draft Guidance for Industry (GFI #210) – The Indexing of Legally Marketed Unapproved New Animal Drugs for Minor SpeciesMargaret Oeller, Center for Veterinary Medicine (HFV-50), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0566, margaret.oeller@fda.hhs.gov
Draft Guidance for Industry – Electronic Exchange of Documents: File Format Requirements – VICH GL53Scott Fontana, Center for Veterinary Medicine, (HFV-100), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0656, scott.fontana@fda.hhs.gov
Draft Guidance for Industry – Bioequivalence: Blood Level Bioequivalence Study – VICH GL52Marilyn Martinez, Center for Veterinary Medicine, (HFV-100), Food and Drug Administration, 7520 Standish Place, Rockville, MD 20855, 240-402-0635, marilyn.martinez@fda.hhs.gov
Draft Guidance for Industry – Combination New Animal DrugsHerman Schoenemann, Center for Veterinary Medicine, (HFV-108), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0652, herman.schoenemann@fda.hhs.gov
Draft Guidance for Industry (GFI #218) – Cell-Based Products for Use in AnimalsLynne Boxer, Center for Veterinary Medicine, (HFV-114), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0611, lynne.boxer@fda.hhs.gov
Draft Guidance for Industry – Designing Effectiveness Studies for Common Animal Production Indications (Growth, Feed Efficiency, Carcass Leanness, Reproduction, Milk Production)Amey Adams, Center for Veterinary Medicine, (HFV-126), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0816, amey.adams@fda.hhs.gov
Guidance for Industry (GFI #23) – Medicated Free Choice Feeds (Revision)Dennis Bensley, Center for Veterinary Medicine, (HFV-140), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0696, dennis.bensley@fda.hhs.gov
Draft Guidance for Industry – Medicated Feed AssaysDennis Bensley, Center for Veterinary Medicine, (HFV-140), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0696, dennis.bensley@fda.hhs.gov
Draft Guidance for Industry – Chemistry, Manufacturing and Controls (CMC) Guidances for Generic New Animal DrugsDennis Bensley, Center for Veterinary Medicine, (HFV-140), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0696, dennis.bensley@fda.hhs.gov
Draft Guidance for Industry – Development of In Vivo In Vitro Correlation (IVIVC) for Sustained Released Injectables (SRI)Gregory Hunter, Center for Veterinary Medicine, (HFV-142), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0675, gregory.hunter@fda.hhs.gov
Draft Guidance for Industry (GFI #57) – Preparation and Submission of Veterinary Master Files (Revision)Gregory Hunter, Center for Veterinary Medicine, (HFV-142), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0675, gregory.hunter@fda.hhs.gov
Guidance for Industry (GFI #219) - Statistical Evaluation of Stability Data - VICH GL51(R)Mai Huynh, Center for Veterinary Medicine (HFV-142), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0669, mai.huynh@fda.hhs.gov
Draft Guidance for Industry – Question-Based Review for Animal DrugsJulie Bailey, Center for Veterinary Medicine, (HFV-145), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0700, julie.bailey@fda.hhs.gov
Draft Guidance for Industry – Submitting Two-Phased Chemistry, Manufacturing and Controls (CMC) Technical SectionsHeather Longstaff, Center for Veterinary Medicine (HFV-145), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0651, heather.longstaff@fda.hhs.gov
Guidance for Industry (GFI #207) – Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food Producing Animals: Marker Residue Depletion Studies to Establish Product Withdrawal Periods – VICH GL48 (Revised)Julia Oriani, Center for Veterinary Medicine, (HFV-151), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0788, Julia.oriani@fda.hhs.gov
Draft Guidance for Industry – Human Food Safety for Protein/Peptide DrugsKimon Kanelakis, Center for Veterinary Medicine, (HFV-153), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0827, kimon.kanelakis@fda.hhs.gov
Guidance for Industry (GFI #116) – Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing – VICH GL23(R)Tong Zhou, Center for Veterinary Medicine, (HFV-153), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0826, tong.zhou@fda.hhs.gov
Draft Guidance for Industry – Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish an Acute Reference Dose (ARfD) – VICHTong Zhou, Center for Veterinary Medicine, (HFV-153), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0826, tong.zhou@fda.hhs.gov
Draft Guidance for Industry – Presenting and Analyzing Target Animal Safety Study DataVirginia Recta, Center for Veterinary Medicine, (HFV-164), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0840, virginia.recta@fda.hhs.gov
Guidance for Industry (GFI #171) – Waivers of In Vivo Demonstration (Revision)John Harshman , Center for Veterinary Medicine, (HFV-170), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0845, john.harshman@fda.hhs.gov
Draft Guidance for Industry – Proprietary Names on Drug LabelingTomislav Modric, Center for Veterinary Medicine (HFV-216), 7519 Standish Place, Food and Drug Administration, Rockville, MD 20855, 240-276-9078, tomislav.modric@fda.hhs.gov
Guidance for Industry (GFI #80) – Studies to Evaluate the Utility of Anti-Salmonella Chemical Food Additives in Feeds (Revised)Xin Li, Center for Veterinary Medicine (HFV-222), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-453-6863, xin.li@fda.hhs.gov
Draft Guidance for Industry – Design and Submission of Distributor LabelingXin Li, Center for Veterinary Medicine (HFV-222), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-453-6863, xin.li@fda.hhs.gov
Draft Guidance for Industry (GFI #220) – Use of Nanomaterials in Food for AnimalsDragan Momcilovic, Center for Veterinary Medicine (HFV-226), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-453-6856, dragan.momcilovic@fda.hhs.gov
Draft Guidance for Industry (GFI #203) – Ensuring Safety of Animal Food Maintained and Fed On-FarmPhares Okelo, Center for Veterinary Medicine (HFV-226), 7519 Standish Place, Food and Drug Administration, Rockville, MD 20855, 240-453-6862, phares.okelo@fda.hhs.gov  
Compliance Policy Guide – Labeling and Marketing of Dog and Cat Food Products Intended to Diagnose, Cure, Mitigate, Treat, or Prevent Diseases (Final)William Burkholder, Center for Veterinary Medicine (HFV-228), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-453-6865, william.burkholder@fda.hhs.gov
Draft Guidance for Industry – Preventive Controls for Food for Animal Foods Under FSMAKim Young, Center for Veterinary Medicine (HFV-230), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-276-9207, kim.young@fda.hhs.gov
Draft Guidance for Industry - Manufacturing, Processing, or Holding Active Pharmaceutical IngredientsJonathan Bray, Center for Veterinary Medicine (HFV-232), 7519 Standish Place, Food and Drug Administration, Rockville, MD 20855, 240-276-9226, jonathan.bray@fda.hhs.gov
Guidance for Industry (GFI #143) – Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms - VICH GL30Margarita Brown, Center for Veterinary Medicine (HFV-241), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-276-9048, margarita.brown@fda.hhs.gov
Guidance for Industry (GFI #214) – Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data - VICH GL35(R)Margarita Brown, Center for Veterinary Medicine (HFV-241), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-276-9048, margarita.brown@fda.hhs.gov



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Tuesday, January 21, 2014

Former pharmacy manager pleads guilty for selling samples- Appalachian News-Express: Home - Former pharmacy manager pleads guilty: Home

Former pharmacy manager pleads guilty - Appalachian News-Express: Home - Former pharmacy manager pleads guilty: Home: A former Pike County pharmacy manager is facing a possible prison

The Law of Compounding Medications And Drugs: Drug Penalty System Next Up in West Virginia

The Law of Compounding Medications And Drugs: Drug Penalty System Next Up in West Virginia: By Tom LaMarra , January 21, 2014 6:35 PM The West Virginia Racing Commission will soon consider a penalty system for drug violation...

The Law of Compounding Medications And Drugs: New animal doping test goes after effects not subs...

The Law of Compounding Medications And Drugs: New animal doping test goes after effects not subs...: Published: Jan 21, 2014 Author: Jon Evans Scientists from the UK, Ireland, France and Switzerland are developing a completely nov...

60 Minutes Poll: More Cheaters Than Jerks in Horse Racing | Paulick Report – Thoroughbred Horse Racing News

60 Minutes Poll: More Cheaters Than Jerks in Horse Racing | Paulick Report – Thoroughbred Horse Racing News

U of I Webinar Will Explain FDA Ruling on Antibiotic Use in Livestock

On Dec. 11, 2013, the U.S. Food and Drug Administration announced important steps to ensure the judicious use of antibiotics in food animals as one approach to addressing antimicrobial resistance in human medicine.
In an effort to clarify what this ruling means to livestock producers and other industry professionals, members of the Department of Animal Sciences at the University of Illinois will offer a webinar to address the new rules on Tuesday, Jan. 28 from noon to 1 p.m.
The discussion will cover what the new steps mean to the livestock industry, what they don't mean, and how producers and others should respond. The webinar will be presented by professor emeritus James Pettigrew and professor Hans Stein.

continue to read here

Racing Free Talk: Paulick Report: AQHA Continues Push for Uniform Me...

Racing Free Talk: Paulick Report: AQHA Continues Push for Uniform Me...: AQHA CONTINUES PUSH FOR UNIFORM MEDICATION, SANCTIONS VIOLATORS 1.18.14, Press Release The Paulick Report see full article here ...

Monday, January 20, 2014

Sunday, January 19, 2014

The Law of Compounding Medications And Drugs: Pennsylvania Veterinary Medical Association- Compo...

The Law of Compounding Medications And Drugs: Pennsylvania Veterinary Medical Association- Compo...: Special Feature! Earn 1 additional hour of CE credit. Charlotte Lacroix, DVM, JD Compounding Drugs and Extra-Label Drug...

The Law of Compounding Medications And Drugs: Extreme Veterinary Compounding

The Law of Compounding Medications And Drugs: Extreme Veterinary Compounding: While most compounding pharmacies routinely tailor-make medications by prescription for dose-adverse humans and domesticated animals, occas...

The Law of Compounding Medications And Drugs: Can veterinarians and pet owners trust compounding...

The Law of Compounding Medications And Drugs: Can veterinarians and pet owners trust compounding...:                        September 24, 2010 With all the bad press veterinary compounding pharmacies got in the last couple of yea...

The Law of Compounding Medications And Drugs: Statutory Law in Kentucky Regarding Veterinary Off...

The Law of Compounding Medications And Drugs: Statutory Law in Kentucky Regarding Veterinary Off...: 201 KAR 2:310. Compounding for a practitioner’s office or institutional administration.         RELATES TO KRS 315.191(1)(a).       S...

Friday, January 10, 2014

Managing Racehorse Joints with Strict Medication Regulations

 

January 09, 2014
In the face of new racing medication rules, vets are revisiting treatment approaches for injured horses.... Read More

Senate Okays Veterinary Medicine Mobility Act

January 10, 2014
Mobile veterinarians are one step closer to better protection from federal drug prosecution.... Read More

Wednesday, January 8, 2014

The Law of Compounding Medications And Drugs: Arizona Board of Pharmacy to discuss and possible ...

The Law of Compounding Medications And Drugs: Arizona Board of Pharmacy to discuss and possible ...: source found here

The Law of Compounding Medications And Drugs: Deadly to Horses: The Baffert Effect – Part 1

The Law of Compounding Medications And Drugs: Deadly to Horses: The Baffert Effect – Part 1: BY JANE ALLIN An article written by Bill Dwyre last month in the Los Angeles Times absurdly glorifies Thoroughbred horse racing’s poster ...

The Law of Compounding Medications And Drugs: Why would anyone administer an anticoagulant to a ...

The Law of Compounding Medications And Drugs: Why would anyone administer an anticoagulant to a ...: BY JANE ALLIN – Continued from Part 1 WHAT TO MAKE OF ALL THIS? Since the sudden deaths of the seven horses there has been much specul...

Warning Letter to DVM for extra label use: 2013 Caldwell Animal Hospital 12/3/13

2013 Caldwell Animal Hospital 12/3/13