Q1 / Q2: CFR 320 may be of some help [Regulatives / Guidelines]

posted by nobody – 2015-05-05 13:19 (3570 d 18:10 ago) – Posting: # 14749
Views: 10,044

...some more:

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm370352.pdf

(with cross-ref to CFR)

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/UCM292571.pdf

...comes down to request controlled correspondence for Q1/Q2, or?

Kindest regards, nobody

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