How to Create an FDA Direct Account in Five Easy Steps

Follow these five steps to create a new FDA Direct account: 

1. Navigate to the FDA Direct main page and click Create New Account. 

2. Select your desired account type. This can be changed after account creation: 

  • CDER Direct – Select this option to register human drug or biological products. You will have access to all drug-related submission forms including Establishment Registration and Drug Listing, Outsourcing Facility Registration and Product Reporting, DSCSA Annual Reporting, and Generic Drug Self-Identification. A complete list of all forms will be shown upon selecting this option. 
  • Cosmetics Direct – Select this option to register cosmetic products only. You will have access to Cosmetic Registration and Listing submission forms. A complete list of all forms will be shown upon selecting this option. 
  • Combined – Full access to both Cosmetics Direct and CDER Direct submission forms. Select this option to register both cosmetic and drug products. This account should be used by companies that manufacture/distribute both drugs and cosmetics. A complete list of all forms will be shown upon selecting this option.

3. Fill out your details in the fields that appear:

*The DUNS field is optional in Cosmetics Direct account creation only.

4. A list of available submission forms will be automatically selected for you at the bottom of the page. If there are any unwanted submission forms in the list, de-select any of the boxes as desired:

5. Click the ‘I have read and agree to the Terms and Conditions stated above’ checkbox at the end of the page. Then click ‘Submit’

An account activation email will be sent from FDADirect@fda.gov to the email address you used in Step 3. Activation links are valid for 48 hours. If your link has expired, you must re-do Steps 15 above.

*Activation email missing or delayed: Check your spam/junk folder first. There may also be a slight delay for DUNS verification, if entered. If you still have not received your activation email after 5-10 minutes, you can contact the Help Desk at: 

CDERDirect@fda.hhs.gov (CDER Direct, Combination accounts) 

OR 

CosmeticsDirect@fda.hhs.gov (Cosmetics Direct accounts)