I have proof.
SEE?
'vie
Saturday, December 14, 2013
Friday, December 13, 2013
FDA Takes Significant Steps to Address Antimicrobial Resistance Agency implementing plan to ensure judicious use of antibiotics in food animals
Animal & Veterinary
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FDA Takes Significant Steps to Address Antimicrobial Resistance
Agency implementing plan to ensure judicious use of antibiotics in food animals
December 11, 2013
Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
Trade Press Inquiries: Siobhan DeLancey, 202-510-4177, siobhan.delancey@fda.hhs.gov
Consumer and Industry Inquiries: AskCVM@fda.hhs.gov
The U.S. Food and Drug Administration today is implementing a plan to help phase out the use of medically important antimicrobials in food animals for food production purposes, such as to enhance growth or improve feed efficiency. The plan would also phase in veterinary oversight of the remaining appropriate therapeutic uses of such drugs.
Certain antimicrobials have historically been used in the feed or drinking water of cattle, poultry, hogs, and other food animals for production purposes such as using less food to gain weight. Some of these antimicrobials are important drugs used to treat human infection, prompting concerns about the contribution of this practice to increasing the ability of bacteria and other microbes to resist the effects of a drug. Once antimicrobial resistance occurs, a drug may no longer be as effective in treating various illnesses or infections.
Because antimicrobial drug use in both humans and animals can contribute to the development of antimicrobial resistance, it is important to use these drugs only when medically necessary. The plan announced today focuses on those antimicrobial drugs that are considered medically important (i.e., are important for treating human infection) and which are approved for use in feed and water of food animals.
In a final guidance issued today, the FDA lays out a road map for animal pharmaceutical companies to voluntarily revise the FDA-approved use conditions on the labels of these products to remove production indications. The plan also calls for changing the current over-the-counter (OTC) status to bring the remaining appropriate therapeutic uses under veterinary oversight. Once a manufacturer voluntarily makes these changes, its medically important antimicrobial drugs can no longer be used for production purposes, and their use to treat, control, or prevent disease in animals will require veterinary oversight.
The FDA is asking animal pharmaceutical companies to notify the agency of their intent to sign on to the strategy within the next three months. These companies would then have a three-year transition process.
“Implementing this strategy is an important step forward in addressing antimicrobial resistance. The FDA is leveraging the cooperation of the pharmaceutical industry to voluntarily make these changes because we believe this approach is the fastest way to achieve our goal,” said FDA Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor. “Based on our outreach, we have every reason to believe that animal pharmaceutical companies will support us in this effort.”
In order to help phase in veterinary oversight of those drugs covered by the guidance that are intended for medically appropriate uses in feed, the FDA also has issued a proposed rule to update the existing regulations relating to Veterinary Feed Directive (VFD) drugs. The use of VFD drugs requires specific authorization by a licensed veterinarian using a process outlined in the agency’s VFD regulations. The VFD proposed rule is intended to update the existing VFD process and facilitate expanded veterinary oversight by clarifying and increasing the flexibility of the administrative requirements for the distribution and use of VFD drugs. Such updates to the VFD process will assist in the transition of OTC products to their new VFD status.
“This action promotes the judicious use of important antimicrobials to protect public health while ensuring that sick and at-risk animals receive the therapy they need,” said Bernadette Dunham, DVM, Ph.D., director of the FDA’s Center for Veterinary Medicine. “We realize that these steps represent changes for veterinarians and animal producers, and we have been working -- and will continue to work -- to make this transition as seamless as possible.”
The guidance for animal pharmaceutical companies is now in final form, and the proposed VFD rule is open for public comment for 90 days starting on Dec. 12, 2013. To electronically submit comments on the proposed VFD rule, go to www.regulations.gov and insert docket FDA-2010-N-0155. Send written comments to the Division of Dockets Management, Food and Drug Administration, Room 1061, 5630 Fishers Lane, Rockville, MD 20852.
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Additional Information
Phasing Out Certain Antibiotic Use in Farm Animals
FDA's Strategy on Antimicrobial Resistance - Questions and Answers
CVM GFI #213 - New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209 (PDF - 115KB)
Veterinary Feed Directive Proposed Rule
CVM GFI#209 The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals (PDF - 251KB)
Judicious Use of Antimicrobials
-
Contact FDA
240-276-9300
240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine
Communications Staff, HFV-12
7519 Standish Place
Rockville, MD 20855
-
-
Page Last Updated: 12/12/2013
Print Share E-mail
HomeAnimal & VeterinaryNews & EventsCVM Updates
-
FDA Takes Significant Steps to Address Antimicrobial Resistance
Agency implementing plan to ensure judicious use of antibiotics in food animals
December 11, 2013
Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
Trade Press Inquiries: Siobhan DeLancey, 202-510-4177, siobhan.delancey@fda.hhs.gov
Consumer and Industry Inquiries: AskCVM@fda.hhs.gov
The U.S. Food and Drug Administration today is implementing a plan to help phase out the use of medically important antimicrobials in food animals for food production purposes, such as to enhance growth or improve feed efficiency. The plan would also phase in veterinary oversight of the remaining appropriate therapeutic uses of such drugs.
Certain antimicrobials have historically been used in the feed or drinking water of cattle, poultry, hogs, and other food animals for production purposes such as using less food to gain weight. Some of these antimicrobials are important drugs used to treat human infection, prompting concerns about the contribution of this practice to increasing the ability of bacteria and other microbes to resist the effects of a drug. Once antimicrobial resistance occurs, a drug may no longer be as effective in treating various illnesses or infections.
Because antimicrobial drug use in both humans and animals can contribute to the development of antimicrobial resistance, it is important to use these drugs only when medically necessary. The plan announced today focuses on those antimicrobial drugs that are considered medically important (i.e., are important for treating human infection) and which are approved for use in feed and water of food animals.
In a final guidance issued today, the FDA lays out a road map for animal pharmaceutical companies to voluntarily revise the FDA-approved use conditions on the labels of these products to remove production indications. The plan also calls for changing the current over-the-counter (OTC) status to bring the remaining appropriate therapeutic uses under veterinary oversight. Once a manufacturer voluntarily makes these changes, its medically important antimicrobial drugs can no longer be used for production purposes, and their use to treat, control, or prevent disease in animals will require veterinary oversight.
The FDA is asking animal pharmaceutical companies to notify the agency of their intent to sign on to the strategy within the next three months. These companies would then have a three-year transition process.
“Implementing this strategy is an important step forward in addressing antimicrobial resistance. The FDA is leveraging the cooperation of the pharmaceutical industry to voluntarily make these changes because we believe this approach is the fastest way to achieve our goal,” said FDA Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor. “Based on our outreach, we have every reason to believe that animal pharmaceutical companies will support us in this effort.”
In order to help phase in veterinary oversight of those drugs covered by the guidance that are intended for medically appropriate uses in feed, the FDA also has issued a proposed rule to update the existing regulations relating to Veterinary Feed Directive (VFD) drugs. The use of VFD drugs requires specific authorization by a licensed veterinarian using a process outlined in the agency’s VFD regulations. The VFD proposed rule is intended to update the existing VFD process and facilitate expanded veterinary oversight by clarifying and increasing the flexibility of the administrative requirements for the distribution and use of VFD drugs. Such updates to the VFD process will assist in the transition of OTC products to their new VFD status.
“This action promotes the judicious use of important antimicrobials to protect public health while ensuring that sick and at-risk animals receive the therapy they need,” said Bernadette Dunham, DVM, Ph.D., director of the FDA’s Center for Veterinary Medicine. “We realize that these steps represent changes for veterinarians and animal producers, and we have been working -- and will continue to work -- to make this transition as seamless as possible.”
The guidance for animal pharmaceutical companies is now in final form, and the proposed VFD rule is open for public comment for 90 days starting on Dec. 12, 2013. To electronically submit comments on the proposed VFD rule, go to www.regulations.gov and insert docket FDA-2010-N-0155. Send written comments to the Division of Dockets Management, Food and Drug Administration, Room 1061, 5630 Fishers Lane, Rockville, MD 20852.
-
Additional Information
Phasing Out Certain Antibiotic Use in Farm Animals
FDA's Strategy on Antimicrobial Resistance - Questions and Answers
CVM GFI #213 - New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209 (PDF - 115KB)
Veterinary Feed Directive Proposed Rule
CVM GFI#209 The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals (PDF - 251KB)
Judicious Use of Antimicrobials
-
Contact FDA
240-276-9300
240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine
Communications Staff, HFV-12
7519 Standish Place
Rockville, MD 20855
-
-
Page Last Updated: 12/12/2013
Hey Dowiii, now you don't have to go to THERE!
And you can see it over and over and over.
And you cab come here instead!
'vie
Let's go, I am ready!
I am, according to momma, a high maintenance dog. I like going out. I mean going for a ride, going shopping, getting cooed at and generally creating a traffic jam by my mere presence.
I put up with momma's schedule and shenanigans up to a point. I mean the woman has all these habits I am just not into. She into cleaning up and doing stuff that frankly has no meaning to me. I put up with all that.
But when I see her putting on earrings, I expect to go out. No ifs, ands or buts. [BTW I have the cutest butt in the universe-that's the truth- ask momma! ]
So, in an attempt to speed up the getting ready to go places process, I got ready on my own.
See?
It is cold out there, my new fur is neat and will keep you warm. I put in on by myself by tunneling inside it. I really love the smooth pink lining and the way it feels. Momma the puparazza had to take a pic. No matter, I am going out! I am happy!
Now get yourself presentable, momma's face does not come from "a" jar, it comes from a whole drawer.
Nuff said.
Do you like going out?
'vie
Thursday, December 12, 2013
What? Are you kidding me? Existential crisis!
The down side of being a blogging four legged is my loss of innocence. This week stories like these have sent me into a full existential crisis.
http://www.nature.com/news/simulations-back-up-theory-that-universe-is-a-hologram-1.14328
If this is true, why can't I have ALL the chewies I want? All of them now, all at once? You can calibrate a hologram to make me appear thinner, right? So what's the point? Gimme all the Chewies now, or gimme a reason.
http://www.nature.com/news/why-lizards-may-inherit-the-earth-1.14355
And then this story! Listen up people, I need something more uplifting and what ever happened to "holiday cheers" anyway?
sigh
'vie
Wednesday, December 11, 2013
This from Rocky, our reporter at large:
Only a patient four legged can calm the savages we call hoomans... Did you know that many law schools have a dog on loan to soothe the law students during exam week? They get to "check out" a dog like a library book for about a hour and they get to de-stress...
If you ask me, we, dogs are the most under appreciated species.
We work better, faster and more predictably than any pharma compound. Get rid of the bottles and the pills and empty the shelters. {Shelter--- that word just makes me want to scream- How is a place where dogs are killed ever come to be known as a "shelter"?????}
Every mall should have staff dogs, every hospital, airport, stadium, etc etc. Where lots of hoomans congregate, a staff dog or two should be present. It's logical.
I have a job here with my family, but there are many competent four leggeds that would love the opportunity to earn their keep.
Think about it America. Lead by example.
Thank you Rocky for your excellent contribution.
'vie
The only good part about this icky weather is
That I finally get to wear my black fur swing coat! I loooooove the pink lining, don't you?
I want momma to get it monogrammed for me and have an inside pocket put in.
Why are you looking at me like that?
Don't you DARE judge me.
I mean it.
Stop it!
It is FAUX and we all know that means it killed nothing except momma's dignity when she bought it!
Stop looking at me like that! I am a serious as a heart attack. I think you are just jealous because I ROCK this look!
Live with it. Where is my fur hat momma??????
'vie
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