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The Center for Veterinary Medicine (CVM) is paving the way for innovation in the animal feed industry! In a recent Letter to Industry, CVM encourages firms developing animal food substances with scientifically substantiated claims related to animal production, well-being, food safety, and environmental benefits to connect early in the product development process. Click here to read the full FDA Letter to Industry.  Key Highlights:  Withdrawal of PPM 1240.3605: CVM intends to withdraw Policy & Procedures read more…

The US Environmental Protection Agency (EPA) has issued a final rule on reporting and recordkeeping requirements for per- and polyfluoroalkyl substances (PFAS) through the Toxic Substances Control Act (TSCA). This rule requires manufacturers and importers to report their PFAS identities, uses, releases, disposals, exposures, health effects, and other information dating back to January 1, 2011.  Notably, the reporting standard requires information “to the extent known or reasonably ascertainable by the manufacturer”; this includes data from read more…

ToxStrategies is pleased to announce that nationally recognized toxicologist Dr. Brent Finley has joined our firm as an Executive Vice President. Dr. Finley brings expertise in all aspects of human health risk assessment and has more than 30 years of experience in consulting. He is a subject-matter expert on numerous chemicals and substances, including PFAS, flavors (e.g., diacetyl), asbestos, lead, chromium, and dioxin. Dr. Finley has been involved in over 400 risk assessments and has published read more…

Neuralace Medical recently received FDA clearance of Axon Therapy for diabetic patients suffering from chronic painful neuropathy. The EpidStrategies medical device trials team of consultants was led by Xiaohui Jiang, Josie Gauthier, Gina Nicholson, and Heidi Reichert. Please contact Heidi Reichert if you would like to learn more about EpidStrategies’ statistical services or our medical device trials team. To read more, click here: Neuralace Medical Announces FDA Clearance of Axon Therapy for Chronic Painful Diabetic Neuropathy read more…

Dr. Naomi Sacks, HEORStrategies Vice President, is a co-author of a study on myasthenia gravis (MG) just published in the journal Neurology. MG is a disorder that affects nerve and muscle communication, leads to chronic muscle weakness, and has a substantial adverse effect on patients’ quality of life. Using data from the National Inpatient Survey (NIS), a representative sample of hospitalizations in the US, and data on hospitalizations from the Medicare Limited Data Set, Dr. read more…

ToxStrategies’ scientists Amy Sheppard and Jennifer van de Ligt collaborated with a team of industry scientists from Cargill to evaluate the safety of supplemental nitrate in pigs. Nitrate supplementation has been studied as a beneficial constituent of the human diet, particularly for its effects on vascular health through vasodilation. Recent studies have focused on benefits of nitrate supplementation in animals, especially in swine. In finishing pigs, growth performance and methemoglobin, the most sensitive safety endpoint, read more…

ToxStrategies will be attending and exhibiting at the International Production & Processing Expo (IPPE) in Atlanta, GA from January 30 to February 1, 2024 ToxStrategies’ consulting scientists have extensive experience in scientific and regulatory affairs, specializing in the animal feed and pet food industries. Our professionals excel in food safety assessments, successfully introducing new ingredients, and enhancing the applications of existing ones. Additionally, we assist manufacturers in substantiating product claims and improving the regulatory landscape read more…

The US Environmental Protection Agency (EPA) has announced that it is beginning the 12-month process to prioritize five additional chemicals for risk evaluation under the Toxic Substances Control Act (TSCA). If the EPA designates these chemicals as High Priority Substances, it will begin risk evaluations for them. The five chemicals are: Acetaldehyde (CASRN 75-07-0), Acrylonitrile (CASRN 107-13-1), Benzenamine (CASRN 62-53-3), 4,4’-Methylene bis(2-chloroaniline) (MBOCA) (CASRN 101-14-4), and Vinyl Chloride (CASRN 75-01-4). Given the widespread use of read more…