Form FDA 3397 is to be completed on-line at www.fda.gov/oc/pdufa/coversheet.html. If you need assistance in completing the form call 301-827-9539 or email: ...

Form FDA 3397 is to be completed on-line at https://userfees.fda.gov/OA_HTML/pdufaCAcdLogin.jsp. If you need assistance in completing the form call 301-796-7200 ...

22 нояб. 2024 г. · The PDUFA Cover Sheet Form FDA 3397 should be completed for the following: 505(b) and 351(a) Original Applications; Resubmission of 505(b) and ...

9 окт. 2014 г. · Payment must be made in US currency by check, bank draft, or US postal money order payable to the order of the US Food and Drug Administration.

24 авг. 2018 г. · ... Instructions.” Instructions: All submissions received must include the Docket No. FDA-2005-N-0101 for “Prescription Drug User Fee Cover ...

25 февр. 2000 г. · INSTRUCTIONS. 1-2. Self-explanatory. 3. PRODUCT NAME - Include generic name and trade name, as applicable. 4.

Use the following instructions to download the form if you encounter an issue: Download / Save As form to your computer; Open Adobe; Open Form from within Adobe.

The Prescription Drug User Fee Cover Sheet is designed to provide the minimum necessary information for FDA to determine whether a fee is required for the ...

following forms: (1) Form FDA 3397 and (2) Form FDA 3971. The information collections of this guidance have been submitted for OMB renewal of approval under ...

9 мар. 2005 г. · Form FDA 3397, the user fee cover sheet, is designed to provide the minimum necessary information to determine whether a fee is required for ...