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| Date | Title of guidance and link to document | Type and level of guidance | About the guidance |
|---|---|---|---|
| 30 Jul 2026 | Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs | Final, Level 1 | This guidance provides recommendations for the design and conduct of studies evaluating the adhesion performance of a transdermal or topical delivery system (collectively referred to as TDS). The recommendations in this guidance relate to studies submitted in support of an abbreviated new drug application (ANDA). Depending on the objectives of a generic TDS product development program, applicants may choose to evaluate TDS adhesion in studies performed to evaluate TDS adhesion only, or in studies performed with a combined purpose(e.g., for the simultaneous evaluation of adhesion and bioequivalence (BE) with pharmacokinetic (PK) endpoints). |
| 30 Jul 2026 | Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs | Draft, Level 1 | This guidance provides recommendations for the design and conduct of studies to evaluate the in vivo skin irritation and sensitization potential of a proposed transdermal or topical delivery system (collectively referred to as TDS2). The recommendations in this guidance relate to studies submitted in support of an abbreviated new drug application (ANDA). This guidance is a second revision to the revised draft guidance Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs (April 2023). This revision provides the following updates to the April 2023 revision of the draft guidance: (1) Clarifies recommendations for the design and conduct of studies to evaluate the in vivo skin irritation (and sensitization, if applicable) potential of a proposed TDS. (2) Clarifies when an in vivo study to assess the sensitization potential of a TDS product may not be needed. |
| 30 Jul 2026 | Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts | Draft, Level 1 | This guidance describes the Agency’s recommendations related to the presentation(s) of proposed therapeutic protein biosimilar or interchangeable biosimilar combination products. For purposes of this guidance, the term presentation means container closure systems (CCS) and device constituent parts. Specifically, this guidance discusses data and information, including the design of studies, to support a demonstration of biosimilarity or interchangeability in an application or supplement submitted under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)). Additionally, this draft guidance expands on and clarifies the Agency’s recommendations and expectations regarding the development of device constituent parts or container closure systems described in Q.I.4 of the guidance for industry entitled “Questions and Answers on Biosimilar Development and the BPCI Act” and the guidance for industry entitled “Considerations in Demonstrating Interchangeability With a Reference Product” for biosimilar and interchangeable biosimilar products, respectively. |
| 27 Jul 2026 | Cancer Clinical Trial Eligibility Criteria: Performance Status | Final | This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of investigational drugs regulated by CDER and CBER for the treatment of cancer, although many of the concepts may apply more broadly to other clinical areas. Specifically, this guidance includes recommendations regarding expanding eligibility criteria to include patients with a wider range of performance status . This guidance is intended to assist interested parties, including sponsors, clinical investigators, and institutional review boards (IRBs), who are responsible for the development and/or oversight of clinical trials. |
| 27 Jul 2026 | Cancer Clinical Trial Eligibility Criteria: Laboratory Values | Final | This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of investigational drugs regulated by CDER and CBER for the treatment of cancer, although many of the concepts may apply more broadly to other clinical areas. Specifically, this guidance includes recommendations for selecting appropriate laboratory values as trial eligibility criteria to avoid unjustified exclusions of trial subjects. This guidance intends to assist interested parties, including sponsors, clinical investigators, and institutional review boards (IRBs), who are responsible for the development and/or oversight of clinical trials. |
| 27 Jul 2026 | Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications | Final | This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of investigational drugs or biological products regulated by CDER and CBER for the treatment of cancer, although many of the concepts may apply more broadly to other clinical areas. Specifically, this guidance includes recommendations regarding the appropriate use of washout periods and concomitant medication exclusions. This guidance is intended to assist interested parties, including sponsors, clinical investigators, and institutional review boards (IRBs), who are responsible for the development and/or oversight of clinical trials. |
| 20 Jul 2026 | Form FDA 3674 – Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions | Final | This guidance describes the FDAs current thinking regarding the types of applications and submissions that sponsors, industry, researchers, and investigators submit to FDA with accompanying certifications (Form FDA 3674) under section 402(j)(5)(B) of the Public Health Service Act (PHS Act), 42 U.S.C. § 282(j)(5)(B). Section 402(j) of the PHS Act was added by Title VIII, Food and Drug Administration Amendments Act of 2007 (FDAAA) (Public Law 110-85). |
| 15 Jul 2026 | Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs | Final, Level 1 | This guidance provides recommendations to industry on formal meetings between the FDA and sponsors or requestors of nonprescription drugs without approved new drug applications that are governed by section 505G of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355h) or organizations nominated by sponsors or requestors to represent their interests in a proceeding. For the purposes of this guidance, a formal meeting includes any meeting that is requested by a sponsor or requestor of OTC monograph drugs or organizations nominated by sponsors or requestors to represent their interests in a proceeding to obtain advice on the studies and other information necessary to support OTC monograph order submissions, to obtain advice on other matters relevant to OTC monograph drug regulation, or to obtain advice on OTC monograph drug development and includes meetings conducted in any format (i.e., hybrid in-person face-to-face, virtual face-to-face video conference, teleconference, and written response only (WRO). |
| 1 Jul 2026 | Submitting Next-Generation Sequencing Data to the Division of Antiviral Products | Final, Level 2 | The purpose of this technical specifications document is to provide the current thinking of FDA’s Division of Antivirals regarding the submission of next-generation sequencing (NGS) protocols, data, and analyses in support of resistance assessments for the development of antiviral drugs. |
| 1 Jul 2026 | Submitting Next-Generation Sequencing Data to the Division of Antiviral Products | Final, Level 2 | The purpose of this technical specifications document is to provide the current thinking of FDA’s Division of Antivirals (the Division) regarding the submission of next-generation sequencing (NGS) protocols, data, and analyses in support of resistance assessments for the development of antiviral drugs. |