Industry will soon be able to use this platform for cosmetics, as well as drug registration and listing submissions. Stay tuned for implementation of FDA Direct, the latest FDA submission tool for drugs and cosmetics with a new look and menu structures. For more details on the cosmetics platform see: FDA Issues Draft Guidance on Registration and Listing of Cosmetic Product Facilities and Products.
Getting Started

To make submissions to FDA (e.g., Establishment Registration, Product Listing and Self-ID, etc.) you must first create an account. Click here to create a new account.


If you already have an account, enter your Username and Password.


WARNING: This warning banner provides privacy and security notices consistent with applicable federal laws, directives, and other federal guidance for accessing this Government system, which includes all devices/storage media attached to this system. This system is provided for Government authorized use only. Unauthorized or improper use of this system is prohibited and may result in disciplinary action and/or civil and criminal penalties. At any time, and for any lawful Government purpose, the Government may monitor, record, and audit your system usage and/or intercept, search and seize any communication or data transiting or stored on this system. Therefore, you have no reasonable expectation of privacy. Any communication or data transiting or stored on this system may be disclosed or used for any lawful Government purpose.


Is your computer secure? Before using FDA's Direct system, FDA strongly encourages you to have current antivirus and antispyware software installed on your computer to help ensure the privacy of the information being entered.


Browser Compatibility: The CDER Direct portal currently works best with the following browsers:

  • Microsoft Edge
  • Firefox version 28 and above
  • Google Chrome
  • Safari 10.0.1 and above

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