US FDA Guidance for Industry – Apr – Jun 2024

DateTitle of guidance
and link to document
Type and level
of guidance
About the guidance
2 May 2024REMS Logic Model: A Framework to Link Program Design With AssessmentDraft, Level 1The purpose of this guidance is to describe FDA’s risk evaluation and mitigation strategy (REMS) logic model. The REMS logic model is a framework that FDA recommends, which provides applicants with a systematic, structured approach to the design, implementation, and evaluation of a REMS. The aim of applying the REMS logic model is to develop clear goals, objectives, and strategies that align with the intended outcomes and to help applicants incorporate the REMS assessment planning into the design of the REMS. The principles in this guidance apply to designing a REMS, developing a REMS assessment, and modifying a REMS.

This guidance is not intended to clarify how risk management or a REMS factors into the benefit-risk assessment of a drug. Although this guidance does not directly address how the Agency determines when a REMS is necessary to ensure that the benefits of the drug outweigh its risks the concepts discussed in this guidance may be relevant to consider when determining if risk mitigation strategies beyond labeling are necessary.
26 Apr 2024Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAsDraft, Level 1This guidance:
• is intended to assist new drug application (NDA) and abbreviated new drug application (ANDA) applicants in submitting an accurate and complete composition statement in their applications and a corresponding statement of ingredients in the DESCRIPTION section of the prescribing information and in other types of FDA-approved labeling (e.g., patient labeling, carton and container labeling) as applicable. Throughout this guidance, the term composition statement refers to information submitted in a drug product’s NDA or ANDA, and the term statement of ingredients refers to information contained in a drug product’s DESCRIPTION section of its prescribing information and other types of FDA-approved labeling, as appropriate.
• provides recommendations for the content and format of the composition 26 statement in the application and the corresponding statement of ingredients in labeling. It provides recommendations for minimizing the number of assessment cycles and communications that are appropriate for approval, as well as ensuring that FDA-approved labeling contains the required qualitative (Q1) and quantitative (Q2) ingredient information.
• includes examples of common, recurring problems FDA has identified during its assessment of NDAs and ANDAs concerning the content and format of the composition statement in the application and the corresponding statement of ingredients in labeling, and this guidance provides applicants with recommendations on how to avoid these problems.
• also describes FDA’s intent, when possible, to use the composition statement submitted in electronic common technical document (eCTD) section 3.2.P.1 of NDAs and ANDAs as the statement of ingredients.
• does not include a comprehensive list of all potential problems in a composition statement or a statement of ingredients. FDA encourages applicants to review applicable FDA regulations and all applicable guidance documents for industry to understand FDA’s current thinking on this topic.
24 April 2024Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for IndustryDraft, Level 1This revised draft guidance addresses questions firms may have when developing FDA-regulated promotional labeling and advertisements (promotional communications)for prescription reference products licensed under section 351(a) of the Public Health Service Act 21 (PHS Act) (42 U.S.C. 262(a)) and prescription biosimilar products, including interchangeable biosimilar products, licensed under section 351(k) of the PHS Act (42 U.S.C. 262(k)).

This guidance:
• does not make any recommendations for nonprescription products. Unless otherwise specified, the term biosimilar product as used in this guidance refers to a product that is licensed under section 351(k) of the PHS Act as biosimilar to or biosimilar to and interchangeable with a reference product.
• discusses considerations for presenting data and information about reference products or biosimilar products in these promotional communications to help ensure that they are accurate, truthful, and non-misleading.

This revised draft guidance replaces the draft guidance for industry Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products: Questions and Answers (February 2020). Changes from the 2020 draft guidance include additional recommendations and an example for interchangeable biosimilar products. In addition, editorial changes were made to improve clarity.
11 April 2024FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological ProductsFinalThe purpose of this technical specifications document is to assist submitters transmitting electronic individual case safety reports (ICSRs) and ICSR attachments to the FDA Adverse Event Reporting System (FAERS) database.

This document describes FDA’s technical approach for submitting ICSRs, for incorporating its regionally controlled terminology, and for adding FAERS regional data elements that are not addressed in the E2B(R3) Electronic Transmission of ICSRs IG for the following FDA-regulated products:
• Drug products marketed for human use with approved NDAs or ANDAs
• Prescription drug products marketed for human use without approved applications, including prescription drug products that are compounded by facilities registered as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353b)
• Nonprescription drug products marketed for human use without approved NDAs or ANDAs
• Biological products with approved biologics license applications (BLAs)
• Combination products with approved NDAs, ANDAs, or BLAs
• Drug and biological products studied under investigational new drug applications (INDs) or IND-exempt bioavailability/bioequivalence (BA/BE) studies supporting ANDAs6
1 Apr 2024Data Integrity for In Vivo Bioavailability and Bioequivalence StudiesDraft, Level 1The purpose of this guidance is to provide recommendations to applicants and testing site management on achieving and maintaining data integrity for the clinical and bioanalytical portions of bioavailability (BA) and bioequivalence (BE) studies submitted in support of INDs, NDAs, and ANDAs, and the bioanalytical portion of clinical pharmacologic studies supporting CDER-regulated BLAs as well as amendments and supplements to these applications. In addition, the recommendations in this guidance apply to the bioanalytical portion of nonclinical studies. FDA also encourages applicants and testing sites to consider these recommendations when conducting other studies, including in vitro and pharmacology and toxicology studies.
1 Apr 2024Study Data Technical Conformance Guide – Technical Specifications DocumentFinalThis Study Data Technical Conformance Guide (Guide) provides specifications, recommendations, and general considerations on how to submit standardized study data using FDA-supported1 data standards located in the FDA Data Standards Catalog (Catalog). The Guide supplements the guidance for industry Providing Regulatory Submissions in Electronic Format — Standardized Study Data (eStudy Data). The eStudy Data guidance implements the electronic submission requirements of section 745A(a) of the Food, Drug, & Cosmetic (FD&C) Act with respect to standardized study data contained in certain INDs, NDAs, ANDAs and certain BLAs that are submitted to CDER or the CBER.
1 Apr 2024Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Guidance for IndustryFinalThis guidance provides instructions for the electronic submission of expedited individual case safety reports (ICSRs) from investigational new drug (IND)-exempt bioavailability (BA)/bioequivalence (BE) studies conducted to support abbreviated new drug applications (ANDAs) to FDA Adverse Event Reporting System (FAERS). An ICSR captures information necessary to support the reporting of an adverse event related to an individual subject that is associated with the use of an FDA-regulated product. The electronic submission of the ICSRs from IND-exempt BA/BE studies is a voluntary option for submitting these required reports.