# Configure FDA Gateway

Set up a Safety FDA Gateway profile to support submissions through the FDA ESG.


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      <p><strong>Note</strong>: 
With the 23R3 release, Veeva Safety <em>AS2 Connections</em> replace Safety Gateways. <em>AS2 Connections</em> provide significant technical improvements including Admin management of Internet Protocol (IP) lists, more concise outbound IP lists, and improved Certificate Management. Though Gateways are still supported, we recommend configuring your Vault to use an
<a href="/en/lr/01451/">FDA AS2 Connection</a>
instead of the FDA Gateway.</p>
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## About Safety FDA Gateway Integration

Safety supports the FDA Electronic Submissions Gateway (ESG) through AS2 (system-to-system) communication. Safety supports CDER, CBER, and CBER VAERS electronic submissions to the FDA.

Vault's integration with the FDA ESG allows you to set up a Gateway Profile for users to submit directly from Safety and receive gateway responses. 

## Types of FDA Electronic Submission Endpoints

The following table outlines the different FDA ESG endpoints that Safety supports and the details for each:

<table>
    <thead>
        <tr>
            <th>Endpoint</th>
            <th>Setup</th>
            <th>Document Format</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td><strong>CDER</strong> (Drugs)</td>
            <td><ul>
                    <li>Register your account with the FDA</li>
                    <li>Configure Sender User</li>
                    <li>Set up the <strong>US FDA ESG</strong> Gateway Profile</li>
                    <li>Set up the <strong>CDER</strong> Transmission Profile</li>
                </ul>
            </td>
            <td>FDA E2B(R2) or FDA FAERS E2B(R3)</td>
        </tr>
        <tr>
            <td><strong>CBER</strong> (Biologics)</td>
            <td><ul>
                    <li>Register your account with the FDA</li>
                    <li>Configure Sender User</li>
                    <li>Set up the <strong>US FDA ESG</strong> Gateway Profile</li>
                    <li>Set up the <strong>CBER</strong> Transmission Profile</li>
                </ul>
            </td>
            <td>FDA E2B(R2) or FDA FAERS E2B(R3)</td>
        </tr>
        <tr>
            <td><strong>CBER VAERS</strong> (Vaccines)</td>
            <td><ul>
                    <li>Register your account with the FDA
                        <br>You can use the same account used to registered with FDA ESG for CBER submissions</li>
                    <li>Configure Sender User</li>
                    <li>Set up the <strong>US FDA ESG</strong> Gateway Profile</li>
                    <li>Set up the <strong>CBER VAERS</strong> Transmission Profile</li>
                </ul>
            </td>
            <td>FDA VAERS E2B(R3)</td>
        </tr>
         <tr>
            <td><strong>CDER Study</strong> (Drugs)</td>
            <td><ul>
                    <li>Register your account with the FDA</li>
                    <li>Configure Sender User</li>
                    <li>Set up the <strong>US FDA ESG</strong> Gateway Profile</li>
                    <li>Set up the <strong>CDER Study</strong> Transmission Profile</li>
                </ul>
            </td>
            <td>FDA FAERS E2B(R3)</td>
        </tr>
        <tr>
            <td><strong>CBER Study</strong> (Biologics)</td>
            <td><ul>
                    <li>Register your account with the FDA</li>
                    <li>Configure Sender User</li>
                    <li>Set up the <strong>US FDA ESG</strong> Gateway Profile</li>
                    <li>Set up the <strong>CBER Study</strong> Transmission Profile</li>
                </ul>
            </td>
            <td>FDA FAERS E2B(R3)</td>
        </tr>
        <tr>
            <td><strong>CDER IND Exempt</strong> (Drugs)</td>
            <td><ul>
                    <li>Register your account with the FDA</li>
                    <li>Configure Sender User</li>
                    <li>Set up the <strong>US FDA ESG</strong> Gateway Profile</li>
                    <li>Set up the <strong>CDER IND Exempt</strong> Transmission Profile</li>
                </ul>
            </td>
            <td>FDA FAERS E2B(R3)</td>
        </tr>
    </tbody>
</table>

## Configure an FDA ESG AS2 Account

Before you can configure the Safety Gateway Profile, you must have an active FDA ESG AS2 account. The <a href="https://www.fda.gov/industry/create-esg-account/setting-as2-account-checklist" target="_blank">FDA Website</a> provides instructions to set up an AS2 account. When you configure your FDA ESG account, ensure that the AS2 URL exactly matches the Vault AS2 URL for your Vault. 



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      <p><strong>Note</strong>: If your organization is a CRO making submissions on behalf of one or more sponsors, you must complete the registration using a single CRO account. Each sponsor will have their own <em>Transmission Profile</em> linked to the same AS2 gateway.</p>
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### Public and Private Certificates

As part of the FDA registration process, you must obtain a public and private certificate pair and send the public certificate to the FDA. If you need help generating these certificates, contact your Veeva Representative.

### Copy Your Vault AS2 URL

1. Go to **Admin > Settings > Gateway Profiles**.
2. Open the appropriate Gateway Profile.
3. Under **Vault AS2 URL**, select **Copy URL**.

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      <p><strong>Note</strong>: Starting in Safety 20R3, the <strong>Vault AS2 URL</strong> contains <code class="language-plaintext highlighter-rouge">/inboundV2/</code>. This change does not affect communication in gateways previously set up with <code class="language-plaintext highlighter-rouge">/inbound/</code>.</p>
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## Configure Sender User

For Submissions to the FDA, you must enter full contact details for the Sender User. This user's information will appear in generated forms and E2B files. The Sender User is assigned on Submission records in the **Sender (User)** field.

<a href="/en/lr/01274/">Managing Roles & Security in Safety</a> provides more information on setting up user contact details. 

An Admin can [configure an FDA ESG Transmission Profile][1] to populate this field with a default Sender User on system generated transmissions based on the Transmission Profile.

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      <p><strong>Note</strong>: If your organization is a CRO making Submissions on behalf of clients, you must configure a separate Sender User for each sponsor. You can leave the Sender (User) field blank on the Transmission Profile so it can be populated based on your sharing settings.</p>
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## Configure the Safety Gateway Profile

Vault comes provisioned with an inactive standard profile for the **US FDA ESG** and **US FDA CBER VAERS**. In order for users to send Submissions to the FDA ESG, you must configure and activate the US FDA ESG Gateway Profile.

### Open the Gateway Profile for Editing

1. In the **Admin** area, go to the **Settings** tab.
2. In the left pane, select **Gateway Profiles**.
3. Open the appropriate Gateway Profile.
4. Select **Edit**. The profile page is unlocked for editing.

### Enter the Gateway Profile Information

1. Under **Details**, in the **Sponsor Email Address** field, enter the Vault user email address to be used as a contact in gateway transmissions.
2. Under **AS2 Profile Configuration**, complete the following fields:
    * **Vault AS2 URL**: Enter the URL where the FDA sends acknowledgments and responses for submissions. The DNS configured in the FDA Gateway Account must exactly match the URL in this field.
    * **Sponsor Certificate**: Select **Choose**, and then open the private encryption certificate. The private certificate is usually a PFX file.
    * **Sponsor Certificate Password**: Enter the password for the sponsor certificate.
    * **Sponsor ID**: Enter the ID registered with FDA Gateway, typically your FDA D-U-N-S number.
    * **Health Authority Certificate**: Select **Choose**, and then open the public encryption certificate received from the FDA during account setup. The public certificate is usually a P7B file.
    * **Health Authority ID**: Enter one of the following FDA identification codes:
      * For a production account, enter `ZZFDA`.
      * For a test account, enter `ZZFDATST`.
    * **Health Authority URL**: Enter the destination FDA Gateway URL.
    * **Gateway User**: Select the Safety user whose name should appear in audit logs and gateway transactions.
3. Select **Save**.
4. To activate the profile, on the top-right corner, select **Set Active**.

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      <p><strong>Note</strong>: The <strong>Gateway User Required</strong> checkbox is automatically populated by the system and is informational only.</p>
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**Result** 

The FDA Gateway Profile is active and available to use to submit case reports to the FDA. 

## <a id="configure-an-fda-esg-transmission-profile"></a>Configure FDA Transmission Profiles

Safety comes with standard, system-provided _Transmission Profiles_ for FDA submissions. You must configure these _Transmission Profiles_ as part of the FDA gateway setup.

The following table lists the system-provided FDA _Transmission Profiles_:

| Transmission Profile | Description | Corresponding Gateway | Routing ID |
| --- | --- | --- | --- |
| _CBER_ | ICSR transmissions to the Center for Biologics Evaluation and Research (CBER) | US FDA ESG | FDA_AERS |
| _CDER_ | ICSR transmissions to the Center for Drug Evaluation and Research (CDER) | US FDA ESG | FDA_AERS |
| _GWTEST_ | Test transmissions to the FDA | US FDA ESG | GWTEST_CONNECTION |
| _CBER VAERS_ | VAERS ICSR transmissions to the Center for Biologics Evaluation and Research (CBER) | US FDA ESG | CBER_VAERS |
| _CBER Study_ | Study data transmissions to the Center for Biologics Evaluation and Research (CBER) | US FDA ESG | FDA_AERS_PREMKT_ CBER |
| _CDER Study_ | Study data transmissions to the Center for Drug Evaluation and Research (CDER) | US FDA ESG | FDA_AERS_PREMKT_ CDER |
| _CDER IND Exempt_ | Study data transmissions for marketed products that are exempt from Investigational New Drugs (IND) requirements | US FDA ESG | FDA_AERS_PREMKT_ CDER |

<a href="/en/lr/01202/">Manage Transmission Profiles</a> provides instructions on setting up Transmission Profiles.

When setting up the Transmission Profiles, see the following guidance on setting the Origin and Destination IDs:

* **Origin ID**: Enter the ID registered with FDA ESG, typically your FDA D-U-N-S number.
* **Destination ID**: Enter one of the following destination IDs:
    * For a production account, enter `ZZFDA`.
    * For a test account, enter `ZZFDATST`.

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      <p><strong>Note</strong>: When editing the FDA Transmission Profiles, do not edit the Routing ID.</p>
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Once you set up the FDA Transmission Profiles, the system uses the appropriate Transmission Profile to generate Submissions based on your Vault's FDA <a href="/en/lr/01252/">reporting rules</a>.

## Configure FDA Study Manual Transmissions

For manual study case report submissions to the FDA to be coordinated outside of Safety, configure the **FDA Study** Transmission Profile.

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      <p><strong>Note</strong>: The FDA is entering a transition period and will be accepting both FDA MedWatch and FDA FAERS E2B(R3) formats. Follow your organization’s procedures for determining how to submit premarket Cases to the FDA. Previously, the FDA Transmission Profile was available to generate and manage manual Submissions for ICSRs in a clinical study using the FDA MedWatch 3500A form.</p>
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<a href="/en/lr/01202/">Manage Transmission Profiles</a> provides instructions on setting up Transmission Profiles.

[1]: #configure-an-fda-esg-transmission-profile