Opportunity
Federal Register #2026-21197
FDA announces support for forward-compatible eCTD Version 4.0 submissions
Buyer
Department of Health and Human Services / Food and Drug Administration
Posted
October 16, 2026
Identifier
2026-21197
The FDA is announcing that its drug and biologics review centers can receive forward-compatible eCTD Version 4.0 submissions. - Government agency: U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA), through the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). - Notice type: Regulatory announcement, not a procurement opportunity. - Capability described: Applicants may submit using eCTD Version 4.0 for applications originally established using eCTD Version 3.2.2. - Notable requirement or effect: The forward-compatible approach supports transition to Version 4.0 while allowing ongoing regulatory activities and lifecycle content submitted under Version 3.2.2 to continue. - Products, services, OEMs, and vendors: None requested or named; no quantities or part numbers are provided.
Description
The FDA is announcing support for Forward Compatibility for electronic submissions based on eCTD Version 4.0, beginning October 16, 2026. This capability enables FDA to process eCTD v4.0 submissions to applications originally established using eCTD v3.2.2. It allows industry to transition to eCTD v4.0 while continuing open regulatory activities and lifecycle content previously submitted under eCTD v3.2.2. Electronic or written comments may be submitted at any time.