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As reported, FDA’s new draft guidance document, ANDA Submissions . 1.1.2 Also contains copy of the GDUFA user fee cover sheet (FDA Form 3794).
Instructions for Completing Form FDA 3794 Generic Drug User Fee Cover Sheet Form FDA 3794 is to be completed on-line at https //userfees. Form FDA 3794, also known as the Generic Drug User Fee Cover Sheet or GDUFA Cover Sheet, is designed to collect the minimum necessary
Listing of all external Forms both OMB approved and state using ORA forms.
IC Title: Generic Drug User Fee Cover Sheet – Form FDA 3794, Agency IC Tracking Number: CDER. Is this a Common Form? No, IC Status: Modified. Obligation
16 Mar 2016 When submitting a DMF, the form “FDA 3794” (Generic Drug User Fee Cover Sheet) should be attached. It contains the minimum information
1 Oct 2012 Instructions for Completing Form FDA 3794. (Generic Drug User Fee Cover Sheet). Form FDA 3794 is to be completed on-line at
The FDA extended the deadline for Type III DMF’s in eCTD to May 2019. Drug User Fee Cover Sheet (otherwise known as form 3794) that applies to Type II
25 Sep 2018 This notice solicits comments on collection of information using Form FDA 3794, entitled “Generic Drug User Fee Cover Sheet.”
26 Jul 2012 Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Drug User Fee Cover Sheet; Form FDA 3794.Proposed Form FDA 3794, the Generic Drug User Fee Amendments Cover Sheet, requests the minimum necessary information from applicants to determine the