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Laurel, MD, United States
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This seminar on veterinary medicine regulations will provide attendees with a comprehensive understanding of FDA's veterinary drug approval process. The U.S. Food and Drug Administration's Center for Veterinary Medicine or CVM is responsible for the approval of veterinary drug products intended for both family pets and food-producing animals. FDA regulates not all products intended for animal use. Jurisdiction over animal products including licensed biologics such as vaccines is shared with a number of other federal agencies. For example, animal vaccines, animal disease diagnostic devices and some animal biologics are regulated by the U.S. Department of Agriculture's Animal and Plant Health Inspection Service or APHIS; and products such as flea and tick collars are regulated by the Environmental Protection Agency. This two day interactive course will cover: - Premarket approval process - Various sections of a New Animal Drug Application - Strategies for navigating the FDA approval process and for expending product approval - The nature of shared jurisdiction over veterinary products in certain cases. - Understand how the U.S. Food and Drug Administration regulates veterinary drug product. - Understand how FDA's Center for Veterinary Medicine is organized. - Discuss the process by which veterinary drug products are reviewed and approved. - Learn how to open an INAD File and request fee waivers. - Obtain a working knowledge of various sections included within an NADA. - Develop a deep understanding of what is needed to substantiate product characterization, target safety and effectiveness. - Analyze FDA's rules governing chemistry, manufacturing and controls or CMC. - Understand the various components of an animal field study to support product approval. - Discuss the difference between FDA's various user fees and fee waivers. - Identify the elements of an FDA compliant label. - Develop a corporate compliance strategy covering labeling, marketing and advertising. - Problem solving methods to mitigate regulatory enforcement risks. - Explain how jurisdiction is split between various Federal agencies in a certain cases. - Learn how animal feed, veterinary devices, OTC drug products and nutritional supplement are regulated in the U.S. Introduction to Veterinary Drug Approval process - FDA's jurisdiction and Center's relevant to Animal Health - Center for Food Safety and Applied Nutrition (CFSAN) - Center for Drug Evaluation and Research (CDER) - Center for Veterinary Medicine (CVM) - Specifics of CVM - Intro to the FDCA, AMDUCA, ADAA, MUMS, etc and guidance (GFI) - Overview of FDCA and regulations - Introduction to FDA GFI Overview of Veterinary Drug Development Discovery/Acquisition - Preliminary Patent Protection Concerns Submissions - Open INAD File - NADA (8 sections) - 5 Major Technical Sections - Chemistry, Manufacturing and Controls (CMC) - Safety (target animal safety study) - Efficacy (field study) - Human Food Safety (human food safety studies for food-producing animals) - Environmental Impact (EA/CE) - 3 Minor Technical Sections - All other information - Labeling - Freedom of Information Summary (FOI) Brief Description of cGxP (GMP, GLP, &GCP) CMC - API: name, structure, properties - API manufacturing - Clinical Trial material - Final Formulation Target Animal Safety - Content and format - Final Study Reports - Monitoring and Reporting Adverse Drug Events Human Food Safety - Analysis of Drug Residues - Toxicology - Residue Chemistry - Microbial Food Safety - Regulatory Method Relied Upon by Sponsor Effectiveness - Dosage Characterization - Substantial evidence (e.g. dose confirmation and clinical field studies) - All other information related to effectiveness - Proposed effectiveness-related labelling - Effectiveness Guidance Documents - The 7 Major Phases of Animal Field Studies - Planning - Study Initiation - In-life Activities - Site close-out - Data management - Biostatistical analysis - Report Writing Approval Process: Chemistry, Manufacturing Controls, Environmental Impact & Managing Clinical Trials - Environmental Impact - Categorical Exclusions - Environmental Assessments (EA) - Common EA Components - Environmental Impact Statements (EIS) - Labeling - FOI - AOI Animal Drug User Fees and Related Fee Waivers - Veterinary Drug User Fees and Fee Reductions and Waivers - Animal Drug User Fee Act (ADUFA) - Applies to Innovators Only - Animal Generic Drug User Fee Act (ADGUF) - Applies to Generic Manufacturers - ANADA sections - CMC - BE (Safety & Efficacy) - HFS - All others - Types of User Fees - Animal Drug Application and Supplement Fee - Animal Drug Product Fee - Animal Establishment Fee - Animal Drug Sponsor fee - Types of Fee Waivers and Reductions - Procedures, Timing and FDA Evaluation of Waivers or Reductions - FDA decision on approval Introduction to FDA's Regulation of Veterinary Feed, OTC Drugs and Supplements - Animal Feed - GRAS - Feed Labeling - AAFCO - Veterinary Feed Directive (VFD) - Veterinary OTC Drugs and Nutritional Supplements - Regulatory Agencies - CVM Compliance Policy - CPG 690.150 & CPG 690.100 - Veterinary Medical Devices CPG 655.100 USDA (CVB, APHIS, FSIS) & EPA - USDA's Animal and Plant Health Inspection Service - Virus Serum Toxin Act - Animal vaccines - Animal biologics - Animal disease diagnostic devices - EPA - Flea & Tick Products - Insect Repellants such as Equine Fly Sprays - State Registrations Non-Approval-Related Considerations - Extra-Label Drug Use - Compounding - Noncompliance and Enforcement - FDA Enforcement Authority over Development, Manufacture, Marketing, and Distribution - FDA's Office of Regulatory Affairs (ORA): Responsible for field activities, imports, inspections, and enforcement policy - Local, State, and Tribal governments - CVM's Office of Surveillance and Compliance - Types of Enforcement Actions Importance of Patent Protection: Right to Enforce For more information about this conference visit http://www.researchandmarkets.com/research/h6p6wc/the_veterinary To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/two-day-veterinary-drug-approval-process-and-fda-regulatory-oversight-course-kansas-city-missouri-united-states---june-13-14-2017---research-and-markets-300444055.html


PubMed | College Park, Crop and Food Research, ESR, Gulf and 8 more.
Type: | Journal: Harmful algae 2002 : proceedings of the Xth International Conference on Harmful Algae, St. Pete Beach, Florida, USA, October 21-25, 2002. International Conference on Harmful Algae (10th : 2002 : St. Pete Beach, Florida) | Year: 2015

A thirteen-laboratory comparative study tested the performance of four methods as alternatives to mouse bioassay for the determination of brevetoxins in shellfish. The methods were N2a neuroblastoma cell assay, two variations of the sodium channel receptor binding assay, competitive ELISA, and LC/MS. Three to five laboratories independently performed each method using centrally prepared spiked and naturally incurred test samples. Competitive ELISA and receptor binding (96-well format) compared most favorably with mouse bioassay. Between-laboratory relative standard deviations (RSDR) ranged from 10 to 20% for ELISA and 14 to 31% for receptor binding. Within-laboratory (RSDr) ranged from 6 to 15% for ELISA, and 5 to 31% for receptor binding. Cell assay was extremely sensitive but data variation rendered it unsuitable for statistical treatment. LC/MS performed as well as ELISA on spiked test samples but was inordinately affected by lack of toxin-metabolite standards, uniform instrumental parameters, or both, on incurred test samples. The ELISA and receptor binding assay are good alternatives to mouse bioassay for the determination of brevetoxins in shellfish.


News Article | December 20, 2016
Site: www.prweb.com

November Research Group, LLC, a global leader in the delivery of product vigilance software to leading biopharmaceutical and medical device manufacturers and regulators, is proud to announce that the company’s PRIMO product vigilance solution has been selected as the new product vigilance software solution for the United States Food and Drug Administration’s (FDA) Center for Food Safety and Nutrition (CFSAN). Mackson Consulting, a Woman Owned Small Business (WOSB) and strategic partner of November Research Group, is the prime contractor for the CFSAN project. Mackson Consulting has broad industry expertise, as well as extensive experience collaborating with the FDA providing award winning IT solutions and professional services. “We chose to propose PRIMO as it was the clear industry leader in Commercial off the Shelf (COTS) solutions in the market, that could meet the review and analysis requirements of the FDA,” stated Mary Biear, President of Mackson Consulting. CFSAN joins the FDA’s Center for Devices and Radiological Health (CDRH) in selecting PRIMO to replace their legacy adverse event systems with a solution geared toward the new era of proactive risk management. CFSAN’s responsibilities span the food and cosmetic industries, which includes the labeling of dietary supplements and food ingredients, post market surveillance and compliance of the food industry, and the safety of cosmetic ingredients. Unlike other commercial AE systems, PRIMO leverages a contemporary architecture to deliver a comprehensive risk management platform built to address the complexity of the challenges faced by manufacturers and regulators. PRIMO provides automation of routine activities while delivering superior analytics and insights. “While PRIMO brings a contemporary solution to the market, it was Mackson’s deep understanding of the CFSAN analysis and case management requirements and their stellar reputation that drove our decision to join their team,” said Tim Howard, President of November Research. November Research Group is a Berkeley, CA based software development company dedicated to delivering commercial product vigilance products for the risk management era. The core team of software developers and quality assurance engineers have been developing software in this domain for over 20 years. They have lead and participated in the development of the most adopted software solutions in this space, including EventNet/Oracle AERS, Relsys/Oracle Argus, and PRIMO. The PRIMO product vigilance platform is positioned to address one or all of the daunting regulatory challenges facing life science groups to provide a Part 11 Compliant solution to inbound email, streamline case intake and triage, deploy mobile and portal AE/PC intake, manage global partner and regulatory submission commitments, and provide medical user access to pharmacovigilance data using powerful queries, all while leveraging an open architecture that embraces integration with emerging cognitive computing technologies. Mackson Consulting LLC, is a Women Owned Small Business (WOSB) delivering IT services to the commercial and public sector markets, with a strong track record delivering on health information technology (HIT) modernization efforts. With a focus on systems engineering modernization and data management solutions, Mackson has been successful in the delivery of health modernization efforts including, but not limited to clinical trials data management and adverse events. Mackson received three separate and distinct industry honors in 2015 including the ACT/IAC 2015 Mobile Technology Award for Best Business investment of the year and multiple awards for innovative health modernization efforts. Mackson continues to lead the industry with expertise in federal health and professional services support.


Grim C.J.,CFSAN | Grim C.J.,Oak Ridge Institute for Science and Education | Kotewicz M.L.,CFSAN | Power K.A.,University College Dublin | And 14 more authors.
BMC Genomics | Year: 2013

Background: Members of the genus Cronobacter are causes of rare but severe illness in neonates and preterm infants following the ingestion of contaminated infant formula. Seven species have been described and two of the species genomes were subsequently published. In this study, we performed comparative genomics on eight strains of Cronobacter, including six that we sequenced (representing six of the seven species) and two previously published, closed genomes.Results: We identified and characterized the features associated with the core and pan genome of the genus Cronobacter in an attempt to understand the evolution of these bacteria and the genetic content of each species. We identified 84 genomic regions that are present in two or more Cronobacter genomes, along with 45 unique genomic regions. Many potentially horizontally transferred genes, such as lysogenic prophages, were also identified. Most notable among these were several type six secretion system gene clusters, transposons that carried tellurium, copper and/or silver resistance genes, and a novel integrative conjugative element.Conclusions: Cronobacter have diverged into two clusters, one consisting of C. dublinensis and C. muytjensii (Cdub-Cmuy) and the other comprised of C. sakazakii, C. malonaticus, C. universalis, and C. turicensis, (Csak-Cmal-Cuni-Ctur) from the most recent common ancestral species. While several genetic determinants for plant-association and human virulence could be found in the core genome of Cronobacter, the four Cdub-Cmuy clade genomes contained several accessory genomic regions important for survival in a plant-associated environmental niche, while the Csak-Cmal-Cuni-Ctur clade genomes harbored numerous virulence-related genetic traits. © 2013 Grim et al.; licensee BioMed Central Ltd.


Grim C.J.,CFSAN | Grim C.J.,Oak Ridge Institute for Science and Education | Kothary M.H.,CFSAN | Gopinath G.,CFSAN | And 6 more authors.
Applied and Environmental Microbiology | Year: 2012

Cronobacter spp. are emerging pathogens that cause severe infantile meningitis, septicemia, or necrotizing enterocolitis. Contaminated powdered infant formula has been implicated as the source of Cronobacter spp. in most cases, but questions still remain regarding the natural habitat and virulence potential for each strain. The iron acquisition systems in 231 Cronobacter strains isolated from different sources were identified and characterized. All Cronobacter spp. have both the Feo and Efe systems for acquisition of ferrous iron, and all plasmid-harboring strains (98%) have the aerobactin-like siderophore, cronobactin, for transport of ferric iron. All Cronobacter spp. have the genes encoding an enterobactin-like siderophore, although it was not functional under the conditions tested. Furthermore, all Cronobacter spp. have genes encoding five receptors for heterologous siderophores. A ferric dicitrate transport system (fec system) is encoded specifically by a subset of Cronobacter sakazakii and C. malonaticus strains, of which a high percentage were isolated from clinical samples. Phylogenetic analysis confirmed that the fec system is most closely related to orthologous genes present in human-pathogenic bacterial strains. Moreover, all strains of C. dublinensis and C. muytjensii encode two receptors, FcuA and Fct, for heterologous siderophores produced by plant pathogens. Identification of putative Fur boxes and expression of the genes under iron-depleted conditions revealed which genes and operons are components of the Fur regulon. Taken together, these results support the proposition that C. sakazakii and C. malonaticus may be more associated with the human host and C. dublinensis and C. muytjensii with plants. © 2012, American Society for Microbiology. All Rights Reserved.


Recently, a taxonomical re-evaluation of the genus Enterobacter, based on multi-locus sequence typing (MLST) analysis, has led to the proposal that the species Enterobacter pulveris, Enterobacter helveticus and Enterobacter turicensis should be reclassified as novel species of the genus Cronobacter. In the present work, new genome-scale analyses, including average nucleotide identity, genome-scale phylogeny and k-mer analysis, coupled with previously reported DNA-DNA hybridization values and biochemical characterization strongly indicate that these three species of the genus Enterobacter are not members of the genus Cronobacter, nor do they belong to the re-evaluated genus Enterobacter. Furthermore, data from this polyphasic study indicated that all three species constitute two new genera. We propose reclassifying Enterobacter pulveris and Enterobacter helveticus in the genus Franconibacter gen. nov. as Franconibacter pulveris comb. nov. (type strain 601/05(T) = LMG 24057(T) = DSM 19144(T)) and Franconibacter helveticus comb. nov. (type strain 513/05(T) = LMG 23732(T) = DSM 18396(T)), respectively, and Enterobacter turicensis in the genus Siccibacter gen. nov. as Siccibacter turicensis comb. nov. (type strain 508/05(T) = LMG 23730(T) = DSM 18397(T)).


Recently, a taxonomical re-evaluation of the genus Enterobacter, based on multi-locus sequence typing (MLST) analysis, has led to the proposal that the species Enterobacter pulveris, Enterobacter helveticus and Enterobacter turicensis should be reclassified as novel species of the genus Cronobacter. In the present work, new genome-scale analyses, including average nucleotide identity, genome-scale phylogeny and k-mer analysis, coupled with previously reported DNA-DNA hybridization values and biochemical characterization strongly indicate that these three species of the genus Enterobacter are not members of the genus Cronobacter, nor do they belong to the re-evaluated genus Enterobacter. Furthermore, data from this polyphasic study indicated that all three species constitute two new genera. We propose reclassifying Enterobacter pulveris and Enterobacter helveticus in the genus Franconibacter gen. nov. as Franconibacter pulveris comb. nov. (type strain 601/05(T) = LMG 24057(T) = DSM 19144(T)) and Franconibacter helveticus comb. nov. (type strain 513/05(T) = LMG 23732(T) = DSM 18396(T)), respectively, and Enterobacter turicensis in the genus Siccibacter gen. nov. as Siccibacter turicensis comb. nov. (type strain 508/05(T) = LMG 23730(T) = DSM 18397(T)).


Carter L.,CFSAN | Lindsey L.A.,CFSAN | Lindsey L.A.,Tuskegee University | Grim C.J.,CFSAN | And 12 more authors.
Applied and Environmental Microbiology | Year: 2013

In a comparison to the widely used Cronobacter rpoB PCR assay, a highly specific multiplexed PCR assay based on cgcA, a diguanylate cyclase gene, that identified all of the targeted six species among 305 Cronobacter isolates was designed. This assay will be a valuable tool for identifying suspected Cronobacter isolates from food-borne investigations. © 2013, American Society for Microbiology.


Jarvis K.G.,CFSAN | Jarvis K.G.,Oak Ridge Institute for Science and Education | Grim C.J.,CFSAN | Grim C.J.,Oak Ridge Institute for Science and Education | And 7 more authors.
Applied and Environmental Microbiology | Year: 2011

Cronobacter (formerly Enterobacter sakazakii) is a recently defined genus consisting of six species, C. sakazakii, C. malonaticus, C. dublinensis, C. muytjensii, C. turicensis, and Cronobacter genomospecies 1. In this study, MboII restriction fragment length polymorphism (RFLP) patterns of O-antigen gene clusters, located between galF and gnd, were used to identify serotypes in Cronobacter spp. Seven O-antigen RFLP clusters were generated, including three C. sakazakii clusters, previously identified as serotypes O1, O2, and O3. The O-antigen regions of six strains with unique RFLP patterns, including two C. sakazakii strains, two C. malonaticus strains, one C. turicensis strain, and one C. muytjensii strain, revealed three O-antigen gene clusters shared among Cronobacter species. PCR assays were developed, targeting the wzx O-antigen polymerase gene, and used to screen 231 Cronobacter strains to determine the frequency of these newly identified serotypes. © 2011, American Society for Microbiology.

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