Regulatory Intelligence

Guidance Tracker

Track what actually changed between different versions of guidance documents, with the source PDFs side by side.

FDA: Evaluation of Therapeutic Equivalence

The core framework — pharmaceutical equivalence + bioequivalence + same clinical effect/safety profile, the A/B TE coding system, and RLD concepts — is unchanged.

Draft (July 2022)Final (August 2026)

FDA: Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products

Substantive revisions around timelines, meeting logistics, and CMC/nonclinical expectations for newer modalities

Draft (November 2024)Final (August 2026)

FDA: Type VII Veterinary Master File for Research and Development and Risk Reviews

The substance of the policy is essentially unchanged. The differences are mostly administrative or legal-status items

Draft (January 2025)Final (August 2026)

FDA: Cancer Clinical Trial Eligibility Criteria: Performance Status

Core recommendations are unchanged — include ECOG PS2 (KPS 60–70) patients by default, consider alternative cohort designs for lower-PS patients, and use additional functional status assessments. The changes below are what shifted between draft and final.

Draft (April 2024)Final (July 2026)

FDA: Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs

The core science — scoring scales, statistical methodology, inclusion/exclusion criteria — is essentially unchanged between the two drafts. The most important change is a structural one: the 2026 revision splits what was previously a single combined study design into two distinct pathways.

Draft Revision 1 (April 2023)Draft Revision 2 (July 2026)

FDA: Cancer Clinical Trial Eligibility Criteria: Laboratory Values

The final guidance adds clinical investigators as an audience, drops the "diversity" framing in favor of "representativeness/applicability," and folds in two new companion guidances.

Draft (April 2024)Final (July 2026 Final)

FDA: Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications

The final guidance keeps the same overall structure and recommendations as the draft, but sponsors should note the narrower treatment of dietary supplements as separate from "concomitant medications"

Draft (April 2024)Final (July 2026 Final)

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