About | HeinOnline Law Journal Library | HeinOnline Law Journal Library | HeinOnline
LOG IN
LOG IN

1 FDA Veterinarian 1 (1986)

handle is hein.animal/fdavt0001 and id is 1 raw text is: 20.9910o WFIDA VETER[NARL4N I MESSAGE FROM THE EDITOR It is with great pleasure that we welcome readers to this new publication from the Food and Drug Administration. We hope and expect that you will find it a valuable source of up-to-date information about veterinary medicine and the regulations governing the animal drug and feeds industries. Many of you have offered support and encouragement in the planning of the FDA Veterinarian. Please let us know how you like it! If you have criticisms and/or sugges- tions about the types of information you would like us to print, please send them to us. We will try to respond quickly to your needs. We would also like to print a Letters to the Editor column. If you have questions to ask of our scientists or observations to make about veterinary issues, send them to us. We will be glad to print them as space is available. Mary-Alice Miller Editor CENTER FOR VETERINARY MEDICINE The Center for Veterinary Medicine (CVM) is one of five Centers of the Food and Drug Administration. The other Centers are: Center for Drugs and Biologics, Center for Devices and Radiological Health, Center for Food Safety and Applied Nutrition, and National Center for Toxicological Research. The primary functions of CVM are to: * Develop and recommend the veterinary medical policy of the FDA with respect to the safety and efficacy of animal drugs, feed additives and devices. * Evaluate proposed and marketed animal drugs, feed additives and marketed de- vices for safety and efficacy. * Coordinate the veterinary medical aspects of FDA in- spectional pro- grams and provide veterinary medical opinions in hear- ings and court cases on related matters. * Plan, direct and evaluate the FDA's surveillance and compliance pro- grams relating to animal drugs, animal feeds and other veterinary medical matters. * Provide policy development and direction on en- vironmental impact * DIVISIONOFTHERAPEUTIC * DIVISIONOFSURVEILLANCE * DIVISIONOFVETERINARY DRUGS FOR FOOD ANIMALS MEDICAL RESEARCH * DIVISION OF COMPLIANCE * DIVISION OF BIOMETRICS AND PRODUCTION DRUGS * DIVISION OF ANIMAL FEEDS * DIVISION OF THERAPEUTIC DRUGS FOR NON FOOD ANIMALS DIVISION OF DRUG MANUFACTURING AND CONTROLS * DIVISION OF VOLUNTARY COMPLIANCE AND HEARINGS DEVELOPMENT matters, in cooperation with other FDA components and Federal agencies. O FDA SEEKS GENERIC REGULATION FOR ANIMAL DRUGS The Drug Price Competition and Patent Term Restoration Act of 1984 authorized abbreviated premarket approvals for ge- neric versions of pioneer human drugs approved after 1962, and restored a portion of the patent protection time lost due to premarket requirements. Animal drugs were not included in this legisla- tion. Animal drug generic legislation has now been introduced in both the Senate and the House of Representatives. Both versions of the legislation would elimi- nate the necessity for full safety and ef- fectiveness testing for generic versions of most post-1962 animal drugs. As with human drugs, the Agency would provide a list of products for which abbreviated new animal drug applications (ANADAs) may be submitted. Currently, a manufacturer who wishes to market an identical or closely-related version of an original post-1962 product must satisfy the requirements for ap- proval of an NADA (including clinical testing to prove safety and effectiveness of the product). That requirement has been a barrier to competition for post-1 962 products. Under a new law similar to the human drug law, the ge- neric manufacturer would have to dem- onstrate only the capability to manufac- ture an equivalent product. An ANADA, therefore, would contain information on the product's formulation, its manufacture, quality control proce- dures, and labeling. Bioequivalence stud- ies would be required to demonstrate that the generic product is equivalent to the pioneer product. Essentially, a ge- neric version of a previously approved product will be the same in active ingre- dient, dosage form and strength, route of administration and conditions of use, including species, as the pioneer prod- uct. The FDA Veterinarian will keep you informed as progress is made on this proposed legislation. O U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR VETERINARY MEDICINE September/October 1986 Vol. I, No. 1

What Is HeinOnline?

HeinOnline is a subscription-based resource containing thousands of academic and legal journals from inception; complete coverage of government documents such as U.S. Statutes at Large, U.S. Code, Federal Register, Code of Federal Regulations, U.S. Reports, and much more. Documents are image-based, fully searchable PDFs with the authority of print combined with the accessibility of a user-friendly and powerful database. For more information, request a quote or trial for your organization below.



Contact us for annual subscription options:

Contact Us

Already a HeinOnline Subscriber?

Log In

profiles profiles most