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Thank you a lot. This is exactly what I was looking for ------------------------------ Mariia Johnson Lawrenceville NJ United States ------------------------------

Dear Colleagues, I'm looking for a guidance for change in manufacturer for phase 2 trial (how much data should be submitted). Also, how much of a stability study data do you need to initiate phase 2 (besides commitment and stability protocol itself) thank you!

Hi there! I've attached current law (FZ.061) in English. There is also information on most recent updates: http://www.lidings.com/eng/legalupdates2?id=320 https://excellishealth.com/wp-content/uploads/2018/01/Dec-28-2017-Russia-Amendments-introducing-TnT-English.pdf ------------ ...

It takes few days usually. Wait till Monday/Tuesday if you submitted your listing on Thursday/Friday. If it doesn't appear then I would recommend to contact FDA helpdesk. ------------------------------ Mariia Johnson, RAC Princeton NJ United States ------------------------------