Agency: Food and Drug Administration
Pages: 1
[FR Doc 03-4741] 1. New Animal Drugs; Phenylbutazone; Extralabel Animal Drug Use; Order of
The Food and Drug Administration (we) is issuing an order prohibiting the extralabel use of phenylbutazone animal and human drugs in female dairy cattle 20 months of age or older. We are issuing this order based on evidence that extralabel use of phenylbutazone in female dairy cattle 20 months of age or older will likely cause an adverse event in
Published: 2003-02-28 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 03-4690] 2. Medical Devices; Hematology and Pathology Devices; Reclassification of
The Food and Drug Administration (FDA) is reclassifying the automated blood cell separator (ABCS) device operating by filtration principle, intended for routine collection of blood and blood components, from class III to class II (special controls). The special control requirement for this device is an annual report with emphasis on adverse
Published: 2003-02-28 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 03-4691] 3. Determination of Regulatory Review Period for Purposes of Patent Extension;
The Food and Drug Administration (FDA) has determined the regulatory review period for ZOMETA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent that claims
Published: 2003-02-28 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
Pages: 1