FDA says CDER has seen significant growth in drug submissions using AI components across the product lifecycle.

Provenance

First verified

2026-05-01

Source updated

2026-05-01

Revision state

Version 1.1 records the September 3, 2026 re-verification and clarifies that FDA describes a submission trend, not approvals, comparative performance, or endorsement.

Last verified

2026-09-03

Status

Current FDA submission-trend statement · not endorsement

Freshness

Current

Version

1.1

Fingerprint

cc9617b16117f4fc

Change sensitivity

Medium

Evidence limits

This is an agency-reported submission trend, not an approval count, comparative-performance finding, or blanket endorsement of an AI method, submission, or output.

Primary source

https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/artificial-intelligence-drug-development

Related signals

• SIG-2026-021 — FDA reports increasing use of AI across the drug-development lifecycle