Configure subject in the report header
On the Subject of Report tab you can select multiple Ingredients for a configured NDA Report per allowable variations of product and license configuration and periodic reporting requirements for the FDA. Select multiple ingredients to view the multiple licenses to be selected for the report.
Field | Description |
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Available Reporting Destinations |
Displays the list of configured Regulatory Agencies. Select an agency from the list displayed in Reporting Destination and click Add to add the report to the Selected Destination list. Select multiple agencies by holding the CTRL key when you click them. |
Selected Reporting Destinations |
Displays the list of agencies where the report is being sent. Select an agency from the list displayed in Reporting Destination and click Add to add the report to the Selected Destination list. Select multiple agencies by holding the CTRL key when you click them. Likewise, select an agency from the Selected Destination list and click Remove to prevent it from being sent to the selected destination. |
Company Name |
If a regulatory agency is selected, the company name associated with the regulatory agency (this association is created by the Administrator) is automatically entered in this field. |
Ingredient |
This field is populated with ingredient selected in the Subject of Report tab. Check the checkbox corresponding to this field to choose whether you want this field to appear on the report. |
Approval |
This field is automatically filled with License numbers, separated by commas. This is an editable field. |
Trade Name |
Automatically displays the Trade Name. Multiple trade names are also populated from license trade name (formulation, concentration) of selected licenses, separated by commas. Check the checkbox corresponding to this field to choose whether you want this field to appear on the report. |
Award Date |
Automatically displays the earliest license awarded date, when a user selects an Ingredient and a Product. Check the checkbox corresponding to this field to choose whether you want this field to appear on the report. |
Print all configuration criteria on separate cover page |
Click this checkbox to print out the configuration of this report when the report is printed. This is only available when the PDF option is selected during printing. |
Print page numbers on reports |
When checked, this option enables the user to print page numbers on a periodic report. This is the default for all report configurations. If this checkbox is not checked, the following occur.
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Allow access to report cases through Hit List |
When the report is run as final, it creates a Hit List, which can be retrieved from other areas of the application where advanced conditions can be selected. Click this checkbox to report cases through the Hit List. |
Parent topic: Prepare content for an NDA periodic report