The burden on a new animal drug
application (NADA) petitioner is not light and includes, but is not limited to, the proffering of (1) adequate tests by all methods reasonably applicable to show whether the drug is safe for use under the conditions suggested in the proposed labeling; and (2) evidence consisting of adequate and well controlled investigations, including field investigation, on the basis of which it could be fairly and reasonably concluded by experts that the drug has the effect it purports to have.
199) Indeed, the latest amendment to section 360b and the animal drug
review process, in general, was passed as the Animal Drug
The FDA regulates medicated feed (FDA 2010a, 2010b) and in doing so separates animal drugs
into two types: therapeutic drugs chat are used to "diagnose, cure, mitigate, treat, or prevent disease in animals," and animal production drugs that are intended only for healthy livestock and used to "enhance the production of edible or nonedible products or to increase the efficiency of a particular phase of life" to increase the rate of weight gain, improve feed efficiency, or enhance milk production (Sechen 2006).
And similar to the user fee agreements this committee reauthorized last year for human medical products, this year we need to reauthorize the Animal Drug
and Generic Drug User Fee Agreements.
Biopharmaceutical company Kindred Biosciences (NasdaqCM:KIN) said on Thursday that it has submitted the Effectiveness Technical Section of the New Animal Drug
Application (NADA) for Zimeta (dipyrone injection, KIND-012) to the US FDA.
BUDGET corned beef has tested positive for banned animal drug
bute and been recalled.
Livestock producers and veterinarians are on edge over a Food and Drug Administration proposal to expand data gathering on antibiotic use in food-producing animals, an issue that is likely to surface when Congress begins debating the animal drug
user fee reauthorization later this year.
The Food and Drug Administration now states that Vetoryl is the only FDA-approved animal drug
containing trilostane as the active ingredient.
640 million for medical device and animal drug
On the other hand, the animal drug
industry claims that using antibiotics on farm animals makes food safer.
Takeda will transfer its animal drug
division to the joint company in June.
In fact, the tests that the FDA used "do not check for certain drugs picked up by the Charm II assay," testified Joseph Settepani, the FDA chemist who first blew the whistle on the FDA's sloppy regulation of animal drug
residues in milk.