To be certified, facilities must meet quality standards for x-ray images, equipment and personnel. At FDA's request, makers of fluoroquinolone antimicrobial drugs are adding warnings to the package inserts about possible tendinitis and tendon rupture. Fluoroquinolones are used to treat bladder, respiratory and other infections. Another warning will alert doctors to the risk. It states that ruptures of the shoulder, hand, and Achilles tendons have been reported and that they required surgery or led to prolonged disability.
Tendon rupture can occur during or after therapy with the drugs.
A new law that lends flexibility to the way FDA regulates animal drugs and medicated feeds is designed to increase the number of animal drugs without compromising the agency's mission to protect the public health. Provide for greater interaction between drug sponsors and FDA during drug development. The law requires a presubmission conference to ensure a common understanding about the data needed to establish safety and effectiveness and the types of studies needed to provide the data. Create a new category of drugs, Veterinary Feeds Directive Drugs, that allows approval and use of sophisticated new animal drugs in feed, while incorporating safeguards to ensure the drugs' safe use. Provide for flexible labeling that permits a range of acceptable or recommended doses on animal drug labeling, rather than one optimum dose.