FDA Updates Withdrawn Product-Specific Guidance List

An August 28 update to CDER's withdrawn product-specific guidances list puts regulatory affairs teams on notice: any ANDA development program anchored to a now-withdrawn guidance carries a strategy gap that requires immediate reconciliation. The update was issued under docket FDA-2007-D-0369 and reflects the agency's ongoing practice of retiring guidances that no longer represent current scientific or regulatory thinking.

Withdrawn guidances do not carry the force of binding regulation, but they shape the bioequivalence study designs, dissolution methodology, and formulation assumptions that sponsors build into development programs. When a guidance disappears from the active list, the evidentiary basis for those assumptions weakens, and a submission built on withdrawn recommendations becomes a potential deficiency target during ANDA review or pre-approval inspection.

For RA directors managing active pipelines, the practical obligation is a line-by-line audit: cross-reference each product in development against the updated withdrawn list, flag any whose regulatory strategy cites or implicitly relies on a retired document, and initiate a gap assessment before the submission window closes. Teams operating under 21 CFR Part 314 should also confirm that any bioequivalence protocols submitted to CDER reflect current, active guidance rather than superseded recommendations.

CDER accepts comments on this guidance document at any time via the federal dockets portal or by written submission to Dockets Management, FDA, 5630 Fishers Lane, Rm 1061, Rockville, MD 20852, referencing docket FDA-2007-D-0369. The comment pathway remains open, giving sponsors a formal channel to flag cases where withdrawal creates ambiguity for products already in late-stage development.

The next measurable checkpoint is the submission date for any ANDA whose bioequivalence or formulation rationale traces back to a guidance now appearing on the withdrawn list.

Source: FDA Center for Drug Evaluation and Research via FDA.gov Drugs RSS Feed, August 28, 2026. Docket: FDA-2007-D-0369.