#1
8th October 2012, 02:21 PM
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FDA NDA checklist
Tell me from where I can get the list of the FDA NDA checklist, I need it too urgent, so will you please provide me, or tell me from where I can get the checklist of FDA NDA?
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#2
9th October 2012, 10:03 AM
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Re: FDA NDA checklist
You want to get form of FDA NDA checklist. You can get it from the below because I have uploaded it here: This will show like: Establishment Information: 1. Drug Substance Manufacturer 2. Drug Product Manufacturer 3. Outside Testing Facility(ies) Establishment information must include the following: Contact name at the manufacturing site and testing laboratories US Agent’s name for each site (if applicable) Address of the manufacturing site for the drug substance and finished product Address of all outside contract testing laboratories Phone and fax numbers, email address of contact for each site Detailed description of function(s) or responsibility(ies) of each |
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