18 December 2012
FDA-CVM to conduct workshop on "Drugs for use in Animal Feeds;" 22-23 May 2013; Potomac, Maryland: A workshop entitled "Drugs for Use in Animal Feeds" will be held on May 22-23, 2013 in conjunction with the American Academy of Veterinary Pharmacology and Therapeutics (AAVPT) Biennial symposium. The workshop is designed to provide interested parties with basic knowledge on the new animal drug approval process specifically relating to medicated feeds. Participants will have an opportunity for clarification on what, exactly, is a medicated feed and how it differs from other dosage form new animal drugs. Topics for discussion include manufacturing requirements, labeling, combination drugs, and developing data for substantial evidence of effectiveness. Finally, participants will have a forum opportunity to ask FDA/CVM specific questions to help clarify their specific needs. For more information click here for the Symposium brochure.
AADAP Publishes New Drug Research Information Bulletin online: The newest DRIB entitled: "The Safety of SLICE® (0.2% Emamectin Benzoate) Administered in Feed to Rainbow Trout Fingerlings" is now available on AADAP's website by clicking here.
Newest issue of "Eddies," a periodic publication of the USFWS's Fisheries andHabitat Conservation Program is now available online: The Summer 2012 issue of Eddies focuses on the Service's Fish and Wildlife Conservation Offices (FWCO's). And in the words of Bryan Arroyo, the Service's current Director for International Affairs (and the past Assistant Director for Fisheries and Habitat Conservation), "...the FWCO's with their cadre of dedicated professionals are the 'trouble-shooters' for fisheries conservation challenges." Click here to view and/or download this issue.
New IPMS User Manual Now Available: A new, greatly improved User Manual for AADAP's INAD Program Management System (IPMS) is now available. To view or download, click on the front cover above or click here.
AADAP's INAD Program Management System finally now online: It has been an awfully long time in the making, but AADAP's web-based INAD Program Management System, or IPMS, is finally online and available for our partners and prospective partners to use. The IPMS replaces our antiquated, labor-intensive and at times prone to transcription and recording errors paper-based system. The IPMS, as in the case of the old paper system, provided the means for AADAP and our investigative partners to use and properly document the efficacy and safety of aquaculture drugs not yet approved by FDA's Center for Veterinary Medicine. The IPMS is totally web-based and is designed to minimize, and hopefully eliminate, errors as well as reduce the recording burden of our investigator partners. To enroll in AADAP's INAD Program or just learn a bit more about the IPMS click here or click on the "INAD Program Management System" button above.
Approved Drugs for Use in Aquaculture Poster - NOW IN STOCK: We now have a new supply of the Drug Posters (jointly sponsored by the USFWS-AADAP, American Fisheries Society's Fish Health and Fish Culture Sections and FDA's Center for Veterinary Medicine). A big thanks goes to FDA's Center for Veterinary Medicine for funding and arranging for a new printing. For information on how to order, or download a printable PDF version, please click here.
Vaccines poster 2nd printing STILL AVAILABLE: At publication time of our last issue of the AADAP Newsletter (November2010), the “Approved Vaccines for Use in Aquaculture” poster was temporarily out of print. However, since then we have arranged for a second printing, and posters are now available and still free-of-charge. To obtain your copy or copies, either click here or go to the following webpage on the AADAP website: http:// tinyurl.com/4ar44yq. The AVMA likewise plans to make the Poster available, details of which can be found on AVMA’s website (http:// www.avma.org).
19 December 2012
AQUI-S®20E and BENZOAK® update:
(eugenol and benzocaine)
A whole bunch of new efficacy studies revisted: read more; page 3.
Channel Catfish Pituitary Update:
Updates on Environmental Safety, Target Animal Safety, Efficacy and Manufacturing: read more; page 3 .
SLICE® target animal safety study completed and under internal review: read more; page 4.
FINS & TAILS, BITS & BOBBERS
19 December 2012
OvaRH® (sGnRHa; injectable) INAD 12-186: The AADAP Office has received a food-use authorization for finfish treated with sGnRHa (OvaRH®). This INAD is now available for National INAD participants to enroll in for calendar year (CY) 2013. We note that sGnRHa (OvaRH®) is an injectable product that has been developed by Western Chemical, Inc., specifically to induce gamete maturation in a broad variety of fish species. Interested participants should contact Bonnie Johnson (firstname.lastname@example.org) to receive a copy of the study protocol and appropriate authorization from FDA/CVM.
INAD Enrollment Open for CY 2013: It is time for the renewal of your facility's INADs for CY 2013. Investigators will need to log into their INAD Program Management System (IPMS) accounts; click on the Account Info tab; click on the “add Drug/INAD” button; and select INADs, fish species, and enter fish number for anticipated use for CY 2013. Please note that INAD participation is not renewed automatically in the IPMS from the previous year, so you will need to have this done before December 31, 2012.
The AADAP INADs currently available are:
- Oxytetracycline medicated feed (Terramycin®200 For Fish)
- Calcein (SEA-MARK®)
- Florfenicol (AQUAFLOR®)
- Oxytetracycline Immersion Therapy (Pennox 343®)
- Carp pituitary
- Ovaplant® (sGnRHa)
- Catfish pituitary
- Diquat (Reward®)
- Hydrogen peroxide (35% PEROX-AID®)
- BENZOAK® (benzocaine)
- AQUI-S®20E (eugenol)
- SLICE® (emamectin benzoate)
- 17-alpha methyltestosterone medicated feed
- OvaRH® (sGnRHa; injectable)
The normal INAD fee of $400 will apply to all INAD signups, with the following exceptions: (1) $600 is charged for the use of 17-alpha methyltestosterone medicated feed; (2) no charge for the AQUI-S®20E and BENZOAK® INADs when treatment is for hatchery use; (3) $200 will be charged for the AQUI-S®20E INAD (per Investigator) when treatment is for field use, with a maximum of $600 charged for each agency/office; and (4) no fee for Federal facilities because the National INAD Office was originally created for Federal INAD use.