The Implications of the FDA’s New Finalized Guidance Documents

The FDA finalized two guidance documents on July 14, closing out review periods that in one case stretched back more than three decades.^1,2 Together, the documents address how sponsors interact with the agency during meetings for over-the-counter monograph drugs, and how generic drug developers should demonstrate that topical corticosteroid products perform the same way as their reference products. Neither document changes what data developers must ultimately generate, but both settle open questions that companies have had to navigate around for years, sometimes relying on outdated methodology or informal agency feedback in the absence of a current final policy.

What Does the New Bioequivalence Guidance Change for Generic Developers?

The corticosteroid guidance, Topical Dermatologic Corticosteroids: In Vivo Bioequivalence, replaces a document the agency first issued in 1995 and updates methodology for pharmacodynamic studies used to support abbreviated new drug applications (ANDAs).¹ It applies across all potency groups of topical corticosteroids and lays out the agency's current thinking on structuring a pilot dose-duration vasoconstrictor response study followed by a pivotal vasoconstrictor bioequivalence study, the pharmacodynamic approach long used as a surrogate for demonstrating that a generic topical corticosteroid delivers the same clinical effect as the branded product.

Compared with the draft version issued in 2022, the final guidance clarifies that subjects used to qualify a chromameter and its operator do not need to be the same subjects enrolled in the pilot or pivotal studies, and it adds a history of hypopigmentation to the list of subject exclusion criteria.¹ For formulation and clinical teams designing an ANDA bioequivalence program, these are the kinds of details that determine protocol structure and subject screening well before a study begins. A clear, current reference reduces the chance of agency feedback arriving only after a study is already underway.

Why Does a Meeting-Procedures Guidance Matter to Product Developers?

The second document, Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs, finalizes a 2022 draft and describes how sponsors request and conduct meetings tied to monograph order submissions under a pathway added to federal drug law in 2020.² It sets out three categories of what the guidance calls Type Y meetings, generally limiting sponsors to one meeting per category over the course of a monograph order development program, and it accommodates in-person, virtual, teleconference, and written-response formats.

The final version also extends the guidance to cover meetings tied to clinical investigations conducted under an investigational new drug application, where the goal is to support a determination that a nonprescription drug is generally recognized as safe and effective, closing a gap sponsors had raised during the comment period.² It also replaces an earlier term, OTC monograph industry working group, with joint meeting requester, to reduce confusion when multiple sponsors coordinate a single submission.

For companies managing over-the-counter monograph portfolios, meeting access and timing directly affect how quickly a monograph order can move forward, and the guidance ties these procedures to updated performance goals under the current monograph drug user-fee program, covering fiscal years 2026 through 2030.² Predictable meeting pathways make it easier to plan submission timelines and allocate regulatory affairs resources across a development program, rather than negotiating meeting scope case by case.

Both guidances are now in effect as the agency's current thinking on these topics, though the FDA notes that sponsors may use an alternative approach if it satisfies the underlying statutory and regulatory requirements.^1,2

References

1. Topical Dermatologic Corticosteroids: In Vivo Bioequivalence; Guidance for Industry; Availability. Federal Register. 2026;91(133):43100-43101. July 14, 2026.
2. Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs; Guidance for Industry; Availability. Federal Register. 2026;91(133):43098-43100. July 14, 2026.