Enable FDA MedWatch 3500A

With the 24R3 release, Veeva Safety generates FDA MedWatch 3500A forms using the version published by the FDA in August 2024. The new version is available in Vault for preview, submission, and distribution of ICSRs for drug, biologic, medical device, and clinical trial cases. After configuring this feature, your Vault generates the August 2024 version of the form only, not the October 2015 version. For more information about field mapping, see FDA MedWatch 3500A (August 2024 Version) Generation Mapping.

26R2 Update: FDA MedWatch 3500A: September 2025 Version

With the 26R2 release, Veeva Safety supports the generation of the latest version of the FDA MedWatch 3500A form, published by the FDA in September 2025. The new version is available for preview, submission, and distribution of ICSRs for drug, biologic, medical device, and clinical trial cases. In addition, this feature introduces an Application Setting that allows you to determine which version of the FDA MedWatch 3500A form your Vault generates. Previously, you had to contact your Veeva Representative to configure the version for your Vault. See (26R2) Configure FDA MedWatch 3500A: September 2025 Version to configure your Vault for the updated feature.

Update the Case Product Layout

Add the Third-party servicer for device? field to the Case Product object layout for devices.

Update the Case Layout

To update the gender fields on applicable Case object layouts:

1. Navigate to Admin > Configuration > Objects > Case > Layouts > [layout].
2. Update the label of the Gender control field to Sex:
   1. To identify the correct field, hover over the existing Gender field and ensure the dialog says Combined Control for: (gender_value__v), (gender_reason_omitted__v)
   2. Select the Edit () icon on the field.
   3. In the Edit Gender dialog, select the Specify different Label and Help Content checkbox.
   4. In the Label field, enter Sex.
   5. Select Done.
3. Add the Gender control field with the Slider () icon. Identify the control field by the name case_gender_identity_control__c.
4. Select Save.

Update the Organization Layout

Add the Manufacturer Site Number field to applicable Organization object layouts.

Update the Product Registration Layout

Add the FDA Product Type field to the Product Registration object layout.

(26R2) Configure FDA MedWatch 3500A: September 2025 Version

To configure which version of the FDA MedWatch 3500A form your Vault generates and support the September 2025 version of the FDA MedWatch 3500A form, complete the following procedures.

Update Submission and Distribution Settings

To configure which version of the FDA MedWatch 3500A form your Vault generates:

1. Navigate to Admin > Settings > Submission and Distribution Settings.
2. Select Edit.
3. In the MedWatch 3500A Version field, select a version of the FDA MedWatch 3500A form.
4. Select Save.

Update the Product Layout

To support the September 2025 version of the FDA MedWatch 3500A form, add the FEI Number field to applicable Product object layouts.