Geoff LeCain

The “Establishments” tab provides the ability to view, create and list all Establishment in the data repository.   To edit an existing Establishment, click on the Establishment’s name in the tabl...

Answer: The FDA is not requiring all inactive ingredients to be listed but is requesting the data be provided. If there is a UNII code for an inactive ingredient, it is expected that you include th...

The “Reset All Section GUIDs” button should only be used if the error listed below is received for a submission: “id must not match any other id across all sections, documents, or any id other th...

The “Establishment Lookup” tab allows users to search and find Establishments that have been registered with the FDA and their associated operations. Type the first three letters of the Establishme...

Answer: You can visit the following link on the FDA site that describes all acceptable types of packaging.http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicS...

The Create SPL button is available only when viewing the Current/Checked-in or Draft/ Checked-out version of the document.  It has 4 options: The “Create SPL for FDA Submission” option generates ...

Answer: You can reuse a delisted NDC after 5 years if it meets the conditions below: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=207.35&SearchTerm=reuse "(ii) When a re...

The “Preview SPL w/ Intagras stylesheet” displays the XML content using the FDA’s stylesheet and exposes the underlying LOINC associated to sections.

The “Preview SPL w/FDA stylesheet” option displays the XML content using the FDA’s style sheet.

Answer: Only users that are defined as administrators in the application have the ability to modify user data. For administrators, navigate to the Admin page and select the “Users” tab (see image b...