FDA Policy/General

9 ICH Vet Med Guidances Published

Federal Register notice: FDA is publishing the following nine guidances released by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products:

(1) Draft guidance for industry entitled “Effectiveness of Anthelmintics: Specific Recommendations for Canines (Revision 1).” To view this notice, click here.

(2) Draft guidance for industry entitled “Effectiveness of Anthelmintics: Specific Recommendations for Equines (Revision 1).” To view this notice, click here.

(3) Draft guidance for industry entitled “Effectiveness of Anthelmintics: Specific Recommendations for Felines (Revision 1).” To view this notice, click here.

(4) Draft guidance entitled “Effectiveness of Anthelmintics: Specific Recommendations for Ovines (Revision 1).” To view this notice, click here.

(5) Draft guidance for industry entitled “Effectiveness of Anthelmintics: Specific Recommendations for Porcines (Revision 1).” To view this notice, click here.

(6) Draft guidance for industry entitled “Effectiveness of Anthelmintics: General Recommendations (Revision 1).” To view this notice, click here.

(7) Draft guidance for industry entitled “Effectiveness of Anthelmintics: Specific Recommendations for Bovines (Revision 1).” To view this notice, click here.

(8) Draft guidance for industry entitled “Effectiveness of Anthelmintics: Specific Recommendations for Caprines (Revision 1).” To view this notice, click here.

(9) Draft guidance for industry entitled “Effectiveness of Anthelmintics: Specific Recommendations for Chickens—Gallus gallus (Revision 1).” To view this notice, click here.

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome