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Laboratory Service Request 11-00064

Consulting and Advisory Services

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Industry: Consulting and Advisory Services


Description: Veterinary Medicine Consultant needed for advice for our drug development to veterinary medicine. I have following questions: 1. This new chemical entity is new in US, but it has been approved and used in Japan since 1985. First of all, we would like to develop it for veterinary medicine in dogs. What kind of studies are required for NADA? What is the estimated cost? How long will it take to the NADA? 2. I know FDA has guideline for "The use of Published Literature in Support of New Animal Drug Approval". We have the most publications without raw data. What do you think if we can waive most animal studies to speed up the development? 3. In Japan, if a drug approved for human use, it will be also approved for animals without additional studies. How is it in USA?


Required Laboratory Location: Anywhere

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