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​​Hi all, I am submitting a 505b2 relying on public  literature data for the non clinical study. Does AHFS (https://www.new.medicinescomplete.com) could be cited as referenced literature? or, considering that AHFS cites data obtained from commercial  product PI, I need to consider that product as a reference ...

​​ Hi, I have a question about NDA module 2 organization. I am writing a module 2 ​(23s and 23p) according to MAPP 5015.10 and the FDA white paper "A Regulatory Perspective on the Quality Overall Summary: Putting the Pieces Together''. Since there are a series of questions (24 questions ...

​​​Hi all, is it possible to submit an NDA without the proprietary name request and submit it 3 months later? thank-you & best regards​ ------------------------------ Alessia Vanzin Lugano Switzerland ------------------------------

​​Hi all, is it possible to submit an NDA without the proprietary name request and submit it 3 months later? thank-you & best regards ------------------------------ Alessia Vanzin Lugano Switzerland ------------------------------

​​Hi, are there any restriction in tables and figures numeration in the dossier chapter? i.e is it acceptable to use hyphens  as Table 3.2.P.2.7.1-1 Are there any problems with the validation connected with  hyphens use? Thank-you for your kind cooperation Alessia ------------------------------ ...