US FDA Guidance for Industry Jan – Mar 2025

DateTitle of guidance and link to documentType and level
of guidance		About the guidance
13 Jan 2025The Office of the Chief Medical Officer (OCMO) has shared the following lists of guidance documents for public review and input:
• Guidance documents it intends to publish in calendar year 2025.
• Guidance documents being developed and intended for publishing in calendar years 2026-2027 as resources permit.

These lists include topics that currently have no guidance associated with them, topics for which updated guidance may be helpful, and topics for which OCMO has already issued draft guidances that may be finalized following review of public comments

You may submit comments on the guidance topics in these lists at www.regulations.gov at Docket FDA-2024-N-5427.

More information at the link below.
Source: FDA
7 Jan 2025Developing Drugs for Optical ImagingDraftThe purpose of this guidance is to provide recommendations to sponsors regarding clinical trial design features that support development and approval of optical imaging drugs that are used in conjunction with imaging devices and intended as intraoperative aids for detection of pathology such as tumors or to enhance the conspicuity of normal anatomical structures.
7 Jan 2025Obesity and Overweight: Developing Drugs and Biological Products for Weight ReductionDraft Level 2 revised guidanceThis guidance:
• provides recommendations to industry regarding the development of drugs and biological products regulated within the Center for Drug Evaluation and Research in the FDA intended for reduction and long-term maintenance of body weight in patients with obesity and those with body mass index (BMI) classified as overweight who also have weight-related comorbidities (hereafter, patients with overweight).
• focuses on the design of trials to demonstrate sustained weight reduction in patients with obesity or overweight. Weight reduction is defined herein as a long-term reduction in excess adiposity (body fat) with a goal of reduced morbidity and mortality. The expression long-term describes the course of body weight observed over a period of at least 1 year on the maintenance dose of the drug.
6 Jan 2025Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is UnderwayDraftFor drugs granted accelerated approval, sponsors have been required to conduct confirmatory studies postapproval to verify and describe the anticipated effect on irreversible morbidity or mortality or other clinical benefit. In the Consolidated Appropriations Act, 2023, Congress amended Section 506(c) of the FD&C Act to provide additional authorities to help ensure timely completion of such trials, including that FDA “may require, as appropriate, a study or studies to be underway prior to approval, or within a specified time period after the date of approval, of the applicable product.” This guidance describes FDA’s interpretation of the term “underway”, and discusses policies for implementing this requirement, including factors FDA intends to consider when determining whether a confirmatory trial is underway prior to accelerated approval.
6 Jan 2025Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological ProductsThis guidance provides recommendations to sponsors and other interested parties on the use of artificial intelligence (AI) to produce information or data intended to support regulatory decision-making regarding safety, effectiveness, or quality for drugs. Specifically, this guidance provides a risk-based credibility assessment framework that may be used for establishing and
evaluating the credibility of an AI model for a particular context of use (COU). For the purposes of this guidance, credibility refers to trust, established through the collection of credibility evidence, in the performance of an AI model for a particular COU. Credibility evidence is any evidence that could support the credibility of an AI model output for a specific COU. The COU defines the specific role and scope of the AI model used to address a question of interest. This guidance does not endorse the use of any specific AI approach or technique.

More on this subject here.
6 Jan 2025Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and AnswersFinal, Level 1This guidance describes FDA’s enforcement policy regarding certain firm-initiated communications of scientific information on unapproved use(s) of the firm’s approved/cleared medical products to health care providers (HCPs) engaged in prescribing or administering medical products to individual patients. Under the FDA Authorities, a firm’s communication about unapproved uses of its approved/cleared medical product could be evidence of the firm’s intended use for such product, and, depending on the facts and circumstances, may be relevant to establishing that the firm has distributed a medical product that fails to comply with applicable premarket requirements or is otherwise misbranded or adulterated. At the same time, in certain circumstances, HCPs may be interested in scientific information about unapproved uses of approved/cleared medical products to inform clinical practice decisions for the care and management of their individual patients.

FDA is issuing this guidance to provide reassurance to firms that, if they choose to provide communications consistent with the recommendations of this guidance, FDA does not intend to use the firm’s dissemination of such communication standing alone as evidence of a new intended use. Additionally, FDA does not expect a firm to submit such a communication to the Agency at the time the communication is initially shared with HCPs.
2 Jan 2025Advanced Manufacturing Technologies Designation ProgramFinal, Level 1This guidance:
• provides recommendations to persons and organizations interested in participating in FDA’s Advanced Manufacturing Technologies Designation Program, which facilitates the development of drugs manufactured using an AMT that has been designated as such under the program (hereinafter designated AMT).
• outlines the eligibility criteria for AMT designation, the submission and assessment process for requests, and the benefits of receiving an AMT designation and includes a questions and answers section to cover additional details about key concepts important for program utilization.

Specifically, the guidance describes:
• The process for submitting an AMT designation request, including a description of eligibility criteria and the data and other information to be included.
• When and how FDA will assess AMT designation requests.
• The process by which FDA will engage with requestors, holders of designated AMTs, and applicants for drugs manufactured using, referencing, or relying upon a designated AMT.
• Benefits related to drug development and application assessment.