Product Family Attributes
The available attributes for a product family depend on the product family type.
Key for Product Family Type:
- FV = flu vaccine
- P = pharmaceutical
- MD = medical device
- PMD = pharmaceutical-medical device
- V = veterinary
- All = all product family types
| Attribute | Product Family Type | Description |
|---|---|---|
| Active Ingredients | FV, P, PMD, V | The active ingredients to associate with the product family by Substance Selection list. If defined in data administration for the active ingredient entity, the compound number is the active ingredient name. |
| Approved Trade Names | FV, P, V, PMD | Trade names that are approved in a PDS for the product family. |
| Associated Trade Names | FV, P, V, PMD | Trade names that are associated, but not approved for the product family. |
| ATC (Available/Selected) | FV, P, PMD, V | The anatomical therapeutic chemical class code in which the product family is categorized. |
| ATC Last Updated | FV, P, PMD, V | The date that the ATC was most recently updated. |
| Development Sponsor | FV, P, PMD, V | Sponsor of the clinical trials. |
| Division | MD, PMD | The division of the Office of Device Evaluation (ODE) Review Divisions with which the product family is associated. |
| Family Code | All | The company-specific code for the product family. |
| Family Name | All | The standard name recognized internally and across countries. |
| International Birth Date | All | For a pharmaceutical product family, the date an approval was first given. For a medical device product family, the date the product family was first launched. |
| Product Family Add Comment | All | Comments you want to share with others in a discussion thread, stamped with the date and time you enter the information and your user ID. |
| Product Family Comments | All | The discussion thread that includes all comments entered by users, including the date and time the comments were entered and the user ID of the person who entered them. |
| Product Family Concerned Parties | All | Users who may be copied on notifications about this entity. Use semi-colons (;) to separate e-mail addresses; click the Search Person icon to choose from available users. |
| Product Family Description | All | Text that describes the product family. |
| Product Family Indications/Intended Use | All | List of all possible indications/intended use for the product family.
When modifying a product family, you cannot disassociate indications/intended use values from the product family if those values are associated with a CTA application. You must first disassociate the indications/intended use values from the CTA before you can disassociate them from the product family. Note: Value is presented in concatenation of
Indications/Intended Use,
MedDRA Level and
MedDRA Version fields.
|
| Product Family Keywords | All | Words you can use to search for the product family. |
| Product Family Status | All | The status of the product family. |
| Product Family Status Date | All | The date the product family status is effective. |
| Product Family Type | All | The type of products associated with this product family (for example, pharmaceutical, medical device). |
| PSUR Data Lock Date | FV, P, PMD, V | The date up to which information is to be compiled for the PSUR. |
| PSUR Due Date | FV, P, PMD, V | When the periodic safety update report is due. |
| Reason | All | Reason for creating, modifying or deleting a product family. |
| Reason for Comments | All | Comments related to reason entered by users. |
| Show in Tree | All | To show or hide product families in the tree on the home page. |
| Therapeutic Area | FV, P, PMD, V | The therapeutic area with which the product family is associated. |
| Therapeutic Classes (Available/Selected) | FV, P, PMD, V | The therapeutic classes in which the product family is categorized. |
| User ID | The user name to validate user identity. | |
| Password | The user password to validate user identity. |