FDA finalized two separate guidance documents for generic and over-the-counter (OTC) drug developers on the same day, July 14, 2026 — one replacing a three-decade-old testing methodology for generic topical corticosteroids, the other formally establishing how FDA meets with sponsors of OTC monograph drugs. Both were published as notices of availability in the Federal Register on July 14, 2026 (document numbers 2026-14119 and 2026-14120), finalizing draft guidances FDA first issued in 2022. Neither is a new regulatory requirement in the statutory sense — both are FDA guidance documents, which describe the agency’s current thinking on how to meet existing requirements rather than creating new ones — but both materially change how sponsors in these two drug categories should plan submissions and agency interactions going forward.
What FDA Finalized for Topical Corticosteroid Bioequivalence
The first guidance, Topical Dermatologic Corticosteroids: In Vivo Bioequivalence Guidance for Industry, gives Abbreviated New Drug Application (ANDA) applicants FDA’s current recommendations for demonstrating that a generic topical corticosteroid is bioequivalent to its reference listed drug. It finalizes a draft first issued in October 2022 and replaces FDA’s original guidance of the same title from June 1995, which relied on an older testing approach.
The finalized methodology uses an in vivo pharmacodynamic (vasoconstrictor) approach, structured around two stages:
- Pilot dose-duration vasoconstrictor-response studies, used to establish the appropriate application duration for the pivotal comparison.
- Pivotal vasoconstrictor bioequivalence studies, which compare the test and reference products using standardized study designs FDA now spells out in detail.
The recommendations apply across corticosteroid potency groups, giving ANDA sponsors a single, current reference point instead of the 1995 methodology many had continued to follow by default for over 30 years. Generic-drug regulatory affairs teams with active or planned topical corticosteroid ANDAs should compare their existing bioequivalence study protocols against the finalized guidance before their next FDA submission or pre-ANDA meeting.
What FDA Finalized for OTC Monograph Formal Meetings
The second guidance, Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs, finalizes a draft FDA first posted in February 2022. It sets out, for the first time in final form, a structured process for how sponsors and requestors under the OTC monograph drug framework can request and conduct formal meetings with FDA.
The guidance defines three meeting types, distinguished by where a monograph stands in the review process:
- Type X meetings — for otherwise-stalled monographs, including products that received a refuse-to-file letter.
- Type Y meetings — milestone discussions for a monograph actively in development.
- Type Z meetings — all other discussions that don’t fit the Type X or Type Y criteria.
It also recognizes four meeting formats — hybrid in-person, virtual face-to-face video conference, teleconference, and Written Response Only — and directs sponsors to submit meeting requests through the CDER NextGen Portal. For OTC monograph sponsors and requestors, this replaces the prior lack of a formal, published meeting-request pathway with defined categories, timelines expectations, and a single electronic intake point.
Why Finalizing Both on the Same Day Is Notable
Neither guidance is a large policy shift on its own — both finalize drafts sponsors have already had years to review (2022 for both). What is notable is that FDA cleared two long-pending final guidances covering different corners of the generic and OTC drug space in a single day, which reads as continued agency progress on working through a backlog of draft guidance documents in the nonprescription and generic-drug areas rather than an isolated, single-topic policy release. Organizations tracking either topic in isolation could reasonably miss that both moved the same week; regulatory affairs and research administration teams that monitor generic or OTC drug policy should treat July 14, 2026 as a single reference date covering both changes.
What This Means for Research Administrators and Regulatory Affairs Teams
For institutions and companies with active generic or OTC monograph drug development programs, the practical implications differ by guidance:
- If your organization sponsors or plans ANDA submissions for topical corticosteroids, review current and planned bioequivalence study protocols against the finalized in vivo vasoconstrictor methodology before your next submission or pre-ANDA meeting request — especially if existing study designs were built around the superseded 1995 guidance.
- If your organization is a sponsor or requestor under the OTC monograph drug framework, build the Type X/Y/Z meeting classification and the CDER NextGen Portal submission process into your regulatory affairs planning now, rather than after a monograph reaches a decision point where a meeting becomes time-sensitive.
- Both guidances are immediately citable in regulatory strategy documents, IRB or sponsor correspondence, and internal SOPs referencing FDA’s current thinking on these two topics — the 1995 corticosteroid guidance and the absence of a formal OTC meeting guidance are both now superseded facts, not current ones.
For the broader regulatory and billing-compliance context these guidances sit within, see CASRAI’s Clinical Research Administration hub. Regulatory affairs teams working across the wider NDA/ANDA post-approval framework may also find the dictionary entry on 21 CFR 314.70 (Changes to an Approved NDA or ANDA) useful background, though note it covers post-approval changes specifically rather than the bioequivalence-testing or meeting-procedure topics addressed here.
Frequently Asked Questions
Are these guidances legally binding requirements?
No. Like all FDA guidance documents, both describe the agency’s current thinking on how to meet existing statutory and regulatory requirements; they are not themselves binding regulations. FDA guidance documents carry significant practical weight, however, since they represent what FDA reviewers will actually expect to see in a submission or meeting request.
Does the corticosteroid guidance apply to brand-name (innovator) topical corticosteroids?
The finalized guidance is written for ANDA applicants seeking to demonstrate bioequivalence to a reference listed drug — that is, it is directed at generic-drug developers, not innovator/brand sponsors seeking initial approval of a new topical corticosteroid product.
Where can I find the full text of both guidances?
Both were published as notices of availability in the Federal Register on July 14, 2026: document 2026-14119 for the topical corticosteroid bioequivalence guidance, and document 2026-14120 for the OTC monograph formal meetings guidance. See the Sources section below for direct links.
Sources
- Federal Register, Topical Dermatologic Corticosteroids: In Vivo Bioequivalence Guidance for Industry; Availability, Document 2026-14119, published July 14, 2026 — federalregister.gov
- Federal Register, Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs; Availability, Document 2026-14120, published July 14, 2026 — federalregister.gov
- Regulatory Affairs Professionals Society (RAPS), “FDA finalizes guidance on formal meetings with OTC sponsors” — raps.org
- FDA, “Guidance Development and Regulatory Assessment of Generic Topical and Dermal Drug Products” (background on the corticosteroid guidance history) — fda.gov
- Justia Regulation Tracker, Federal Register mirrors for documents 2026-14119 and 2026-14120 — regulations.justia.com
