Food and Drug Administration (FDA)

…The US Food and pain resulting from surgical castration. This methodology will Drug Administration (FDA) has oversight of approval and safety use multiple outcome variables to, in summation, demonstrate of all products…

…The US Food and pain resulting from surgical castration. This methodology will Drug Administration (FDA) has oversight of approval and safety use multiple outcome variables to, in summation, demonstrate of all products…

…In addition, approval from the Food and Drug Administration (FDA) is required in order for producers or caretakers to administer such pain relief drugs without oversight by a veterinarian. Given these challenges…

…In addition, approval from the Food and Drug Administration (FDA) is required in order for producers or caretakers to administer such pain relief drugs without oversight by a veterinarian. Given these challenges…

…US Food and Drug Administration. CVM GFI #197 Documenting Electronic Data Files and Statistical Analysis Programs. Available online: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-197-documenting…

Posted on Authorea 16 Sep 2020 — The copyright holder is the author/funder. All rights reserved. No reuse without permission. — https://doi.org/10.22541/au.160029789.93744641 — This a preprint and has not been peer reviewed. Data may be preliminary. Efficacy and application of a novel topical anaesthetic wound formulation for treating cattle with Foot-and-Mouth disease: a field trial in Cameroon Sevidzem Lenze1 , Jacques Mavoungou1 , Kong Burinyuy1 , Koumba Armel1 , Simon Dickmu1 , James Young2 , Peter Thomson3 , and Peter Windsor2 1 Affiliation not available 2 University of Sydney 3 School of Life and Environmental Sciences September 16, 2020 Abstract Recently, a wound dressing formulation, (Tri-Solfen®, Medical Ethics Pty Ltd, Australia; TS) registered for use in ruminant husbandry in Australia, was registered for Foot-and-Mouth Disease (FMD) therapy in large ruminants in Laos, following clinical observations of improved welfare and healing following treatment of FMD lesions. In November 2019, an FMD outbreak in Cameroon provided an opportunity for a field trial, comparing clinical responses and recoveries to treatments on a sample of cattle (n = 36) comprising three equal groups of animals (n = 12), comparing responses to three treatments:(i) the application to lesions of TS, (ii) the administration of parenteral oxytetraycline commonly used for FMD in Cameroon; and (iii) an untreated control group (C). Appetite scores, lesion healing scores, and changes in dimensions of lesions, were recorded over a 15-day study period. Cattle treated with TS achieved both superior appetite and lesion healing scores with more rapid reduction in dimensions of lesions than other groups. Farmer observations indicated the TS treatment group had a more rapid return to eating with

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oon; and (iii) an 7 School of Life and Environmental Sciences, untreated control group (C). Appetite scores, lesion healing scores, and changes in The University of Sydney, Camden, NSW, dimensions of lesions, were recorded over a 15-day study period. Cattle treated with Australia TS achieved both superior appetite and lesion healing scores with more rapid reduc- Correspondence tion in dimensions of lesions than other groups. Farmer observations indicated the TS Peter A. Windsor, Sydney School of Veterinary Sciences, The University of treatment group had a more rapid return to eating with cessation of excessive saliva- Sydney, Camden, NSW, Australia. tion, and more rapid return of mobility (walking) with absence of overt lameness. The Email: peter.windsor@sydney.edu.au findings indicate that although mortality is usually low in FMD outbreaks, the disease is a debilitating and painful disorder with negative animal welfare impacts that should be addressed. All farmers expressed their desire that the product be made available for use in their region and modelling indicates that TS therapy imposes no additional financial burden on farmers, with the treatment likely to be provided at a similar or reduced cost to current treatment choices. As use of antibiotics for treatment of a viral disease potentially increases pressures for development of antimicrobial resist- ance and residues in the food chain, TS as an alternative non-antimicrobial therapy should be promoted for wider use in FMD outbreaks. KEYWORDS animal welfare, Cameroon, cattle, foot-and-mouth disease, therapeutic efficacy This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly