Understanding FDA Direct: A Powerful Tool for Regulatory Submissions

FDA Direct is a web-based platform developed by the U.S. Food and Drug Administration (FDA) to streamline the submission of regulatory information. This free tool is designed to support businesses in meeting FDA compliance requirements through a user-friendly interface for Structured Product Labeling (SPL) submissions.

Previously known as CDER Direct, the platform has been enhanced to include two dedicated modules: CDER Direct and Cosmetics Direct. These updates expand the platform’s capabilities, providing a more comprehensive solution for businesses in the pharmaceutical and cosmetic industries.

Key Features of FDA Direct

FDA Direct allows users to create and manage submissions in two distinct areas:

CDER Direct
CDER Direct is designed for drug-related submissions to the FDA’s Center for Drug Evaluation and Research (CDER). Users can submit data for:

  • Establishment Registration & Drug Listing – Including registering manufacturing facilities, requesting NDC labeler codes, and listing or certifying drug products.
  • Outsourcing Facility Registration and Product Reporting – For compounded drug product reporting and facility registration.
  • DSCSA Annual Reporting – For Wholesale Drug Distributors (WDD) and Third-Party Logistics (3PL) providers to submit facility and license information.
  • Generic Drug Self-Identification – Required for generic drug manufacturers under GDUFA regulations.

Cosmetics Direct
Cosmetics Direct supports submissions related to compliance with the cosmetic industry. Users can submit:

  • Cosmetic Product Facility Registration – Registering facilities involved in cosmetic product manufacturing or distribution.
  • Cosmetic Product Listing – Submitting detailed product information for FDA review.

Combined Account
For companies that manage both drugs and cosmetics, FDA Direct offers a Combined Account option. This allows businesses to access both CDER Direct and Cosmetics Direct through a single profile, simplifying account management and submission processes.

Accessibility and Compliance

FDA Direct is designed to meet Section 508 of the Rehabilitation Act, which requires federal electronic and information technology to be accessible to individuals with disabilities. This ensures that all users, including those with visual or physical impairments, can navigate the platform effectively.

Why Use FDA Direct?

FDA Direct simplifies the process of submitting essential regulatory information. By offering a clear structure, intuitive interface, and distinct account options, the platform helps businesses in the pharmaceutical and cosmetic industries stay compliant with FDA regulations. Whether you’re registering a new facility, reporting product details, or managing both drug and cosmetic submissions, FDA Direct offers an efficient solution for ensuring your data reaches the FDA accurately and securely.

For businesses looking to expand into regulated markets or meet updated compliance standards like MoCRA (Modernization of Cosmetics Regulation Act), FDA Direct is an essential tool that supports seamless reporting and registration.