Product Family Attributes
The available attributes for a product family depend on the product family type.
You see only the attributes available for 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 | 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. By default, the field is hidden. |
| 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 | Anatomical therapeutic chemical class code in which the product family is categorized. |
| Development Sponsor | FV, P, PMD, V | Sponsor of the clinical trials. By default, the field is hidden. |
| Division | MD, PMD | Division of the Office of Device Evaluation (ODE) Review Divisions with which the product family is associated. By default, the field is hidden. |
| Family Code | All | Company-specific code for the product family. |
| Family Name | All | 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. By default, the field is hidden. |
| 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 | 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. 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 | Status of the product family. By default, the field is hidden. |
| Product Family Status Date | All | Date the product family status is effective. By default, the field is hidden. |
| Product Family Type | All | Type of products associated with this product family (for example, pharmaceutical, medical device). |
| PSUR Data Lock Date | FV, P, PMD, V | Date up to which information is to be compiled for the PSUR. By default, the field is hidden. |
| Generic Name | FV, P, PMD, V | Generic name given to a product family. By default, the field is hidden. |
| PSUR Due Date | FV, P, PMD, V | When the periodic safety update report is due. By default, the field is hidden. |
| 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 | Therapeutic area with which the product family is associated. By default, the field is hidden. |
| Therapeutic Classes (Available/Selected) | FV, P, PMD, V | Therapeutic classes in which the product family is categorized. By default, the field is hidden. |
| User ID | User name to validate user identity. | |
| Password | User password to validate user identity. |