Impact: Changes: — All animals treated with PROPOSAL1PC65 must undergo the clinical trial of such medicine, as described in this new chapter.
SUMMARY: The proposed rule addresses the requirement that animal drugs be registered under the Federal Food, Drug, and Cosmetic Act (FDA) before the drug can be marketed in the United States. The regulatory proposal revises, updates, or eliminates the requirement of a “biologic drug product application” to register animal drugs for human use prior to their marketing. It also revises, updates, or eliminates the requirement for animal drugs to undergo clinical trials in the United States prior to marketing.
The regulatory proposal is the first of three proposals under FDA jurisdiction that address the registration and labeling requirements for animal drugs. The proposed rule would have the greatest impact on the following drugs (see FDA's Drugs — Animal Testing : Overview for a list of animal drugs, along with the FDA's Animal Drugs — List of List-Only Animals and the FDA's Food Animal Drug Notification Form, for more information): Pfizer's Native in oral form, including products marketed to treat spasticity; Eli Lilly's Lyrics in rectal formulation; Novartis' Physio in the ear and nasal mucosa; Bringer Ingelheim's Fountain in oral form, including products marketed to treat spasticity and the oropharynx; Baxter's Biodesign in rectal, subcutaneous, and injectable forms and in oral, subcutaneous, and injectable form; Toronto in oral form; Bovine Alopecia, an animal drug used in the management of testosterone deficiency; Merck's Enamel in the vagina and male urethra; AstraZeneca's Ciprofloxacin in the rectal and recto vaginal route; and Lilly's Zofran in rectal and recto vaginal route. The proposed rule also addresses whether a drug product must be included on the FDA's “Priority List” under the FDA's ``New Animal Drug Program,'' by re-categorizing some animal drugs on the Priority List.
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51276 Federal Register / Vol. 71 No. 167 / Tuesday August 29 2006 / Proposed Rules DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 20 201 207 314 330 514 515 601 607 610 and 1271 Docket No. 2005N 0403 RIN 0910 AA49 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs Including Drugs that are Regulated Under a Biologics License Application and Animal Drugs AGENCY HHS. jlentini on PROD1PC65 with PROPOSAL2 ACTION Proposed...
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