Friday, December 8, 2017


US Compounding develops compound to manage equine ulcers
Adamis Pharmaceuticals Corp. announced that its subsidiary, US Compounding, has developed a compound to manage ulcers in horses. A study, utilizing US Compounding's drug formulation, was conducted in approximately 50 racehorses. Gastric endoscopy was performed at Day 0 and any time ..

Thursday, December 7, 2017

Toxicology testing plays a pivotal role in ensuring the safety of FDA-regulated products. During the development and evaluation of almost all FDA-regulated products, testing is performed on people or animals to identify any potential risk from chemical, physical, or biological agents.
Today, novel methods such as organs on a chip or mathematical modeling are being developed for toxicity testing that are generating unique opportunities to improve our ability to quickly and more accurately predict potential toxicities and reduce associated risks.   
This week the agency’s Toxicology Working Group laid out FDA’s Predictive Toxicology Roadmap, a six-part framework for integrating predictive toxicology methods into safety and risk assessments. Among other recommendations, it calls for FDA research to identify data gaps and to support intramural and extramural research to ensure that the most promising technologies are developed, validated, and integrated into the product pipeline. The roadmap also identifies toxicology issues that need addressing for FDA-regulated products and toxicology areas that could benefit from improved predictivity.


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