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

8 FDA Veterinarian 1 (1993)

handle is hein.animal/fdavt0008 and id is 1 raw text is: ary/February 1993 Vol. VIII, No. I ( I YFDA VETERINARL4N WORKSHOP EXAMINES BIG PROBLEMS OF SMALL RUMINANTS O n October 22-23, 1992, FDA sponsored the sixth IR-4/FDA Workshop for Minor Use Drugs which focused on the health and drug needs of small ruminants such as sheep, goats, deer, and llamas. Participants at this workshop, held in Bethesda, MD, included representatives from govern- ment, academia, industry, and pro- ducer groups. Originally, Interregional Research Project No. 4 (IR-4) was created by USDA to develop data for use in estab- lishing tolerances for pesticide residues to permit legal use of these pesticides on minor species plants. The project was very successful and was ex- panded in 1983 to include research on animal drugs for use in minor species. The IR-4 Animal Drug Project is a na- tional program dedicated to developing new drugs for use in minor animal spe- cies or in any animal species for the control of a disease that occurs infre- quently or in limited geographical areas. Minor species include animals other than cattle, swine, chickens, turkeys, horses, dogs, and cats. Sheep have been considered a major species when it is necessary to acquire data to show human food safety, but a minor spe- cies when the data demonstrate only animal safety and effectiveness. The IR-4 Project is funded by the U.S. Department of Agriculture's Cooperative State Research Service. In 1992, the program was funded at a level of $450,000. FDA has also con- tributed to the IR-4 Project by assign- ing a full-time employee to coordinate the activities of the program, conduct- ing workshops to discuss important IR- 4 issues, funding extramural research in minor species, and conducting tissue residue and milk depletion analysis to meet the human safety requirements in several minor species. The IR-4 Project concentrates on gaining approval for drugs for minor species or minor uses for which there is a lack of economic incentive for drug companies. For example, there is a scarcity of approved drugs for many diseases of animals such as goats, sheep, and fish. However, the cost of developing a drug for these species through an approved new animal drug application (NADA) could exceed profits likely to be obtained by phar- maceutical manufacturers. Producers of minor species have been handicapped by the limited num- ber of drugs approved for use in these animals. If diseases in these species are not treated, there may be severe injury to target animals as well as potential B ORDERS 8/92 public health hazards to humans. Producers who need to treat their animals are forced to use unapproved drugs which are not necessarily safe and effective. The IR-4 program has generated re- search for approval of needed minor use veterinary drugs. FDA allows data on a drug for use in a closely related major species of animal to be used to support the approval of a similar indi- cation in a minor species. Manufac- turers of drugs for major species may (Continued, next page) In This Issue: Combination Drug Approval W ithdrawn ............. 4 Defining Food and Non- Food Fish .............. 6 1991 ADR Summary .... 1-13 Carcinogenic Pesticides . . . . 10 U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR VETERINARY MEDICINE

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