Guidance for Industry 213
See the following -
Animal Health Institute Statement On FDA Final Guidance 213
The Animal Health Institute (AHI) issued the following statement in response to the Food and Drug Administration’s publication of the final Guidance 213 and proposed VFD rule implementing the policy of extending veterinary oversight and eliminating the subtherapeutic use of medical important antibiotics in animal agriculture. Read More »
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FDA Antimicrobial Resistance Guidelines Fail to Address Root Causes
Last December, the Food and Drug Administration (FDA) published two controversial documents on its website: Guidance 213 and the Veterinary Feed Directive (VFD). The guidelines stirred a firestorm of protests from public health offiicials who argue that the guidelines are too weak to prevent the continuing growth of antibiotic resistant germs...the crisis, as outlined by Dr. Joseph Mercola, is that we are now "facing the perfect storm to take us back to the pre-antibiotic age, when some of the most important advances in modern medicine – intensive care, organ transplants, care for premature babies, surgeries and even treatment for many common bacterial infections – will no longer be possible." Read More »
FDA Update On Animal Pharmaceutical Industry Response To Guidance #213
On December 11, 2013, the FDA announced the implementation of its plan to help phase out the use of medically important antimicrobials in food animals for food production purposes. [...] FDA asked affected sponsors to notify the agency in writing within three months, or by March 12, 2014, of their intent to engage with FDA as defined in Guidance for Industry (GFI) #213. Read More »
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Re-Examining The FDA Antibiotics Decision: Banning Growth Promoters Won’t Be Enough
In my first take on the news of the FDA finalizing its request to agriculture to stop using growth-promoter antibiotics, I promised to come back for a more thoughtful reaction. And then this happened, and this happened, and the holidays happened, and, well, it’s been a busy few weeks. Read More »
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Warren Questions FDA Commissioner About Antibiotics Guidance
The issue of antibiotics in animal feed reared its head again Thursday as U.S. Sen. Elizabeth Warren (D-MA) questioned Food and Drug Administration Commissioner Margaret Hamburg about the effectiveness of Guidance 213 during a Senate Committee on Health, Education, Labor and Pensions (HELP) hearing. Read More »
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