US FDA Guidance for Industry Jan-Mar 2026

DateTitle of guidance and link to documentType and level
of guidance		About the guidance
6 Mar 2026Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP InspectionDraft, Level 1This guidance is intended for foreign and domestic human and animal drug manufacturing establishments inspected by FDA whose drugs are regulated by CDER, CBER, and CVM. This guidance is also intended for combination
product manufacturers where CDER or CBER is the lead Center.
The purpose of this guidance
is to assist drug manufacturers who choose to respond to FDA when they receive an FDA Form 483 Inspectional Observations (FDA 483) at the conclusion of an inspection to assess conformity
with current good manufacturing practice (CGMP).
3 Mar 2026M14 General Principles on Planning, Designing, Analyzing, and Reporting of Non-interventional Studies That Utilize Real-World Data for Safety Assessment of MedicinesFinalThe purpose of this guidance is to recommend international standards for, and promote harmonization of, the general principles on planning, designing, analyzing, and reporting of noninterventional studies that utilize fit-for-use (frequently referred to as fit-for-purpose) data for safety assessment of medicines (drugs, vaccines, and other biological products). The Glossary
defines many of the terms for the purpose of this of this guidance. Words or phrases found in the Glossary appear in bold italics at first mention.
2 Mar 2026E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety ReportsFinal, Level 1This guidance provides recommendations that are harmonized to the extent possible given
differences in postmarket safety reporting requirements among ICH regions. Where applicable, this guidance notes where regional and local requirements may vary and, as such, marketing
authorization holders (MAHs) should refer to the relevant regional or local regulatory authority’s
requirements.
2 Mar 2026New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and AnswersDraft, Level 1This guidance is intended to assist applicants requesting New Clinical Investigation exclusivity (also referred to as 3-year exclusivity) for a new drug application (NDA) or NDA supplement under sections 505(c)(3)(E)(iii)-(iv) and 505(j)(5)(F)(iii)-(iv) of the FD&C Act. The guidance discusses the statutory and regulatory criteria for eligibility for New Clinical Investigation exclusivity and provides recommendations on the content and format of requests for New Clinical Investigation exclusivity in the form of questions and answers (Q&As). FDA intends to update this draft guidance document to include additional Q&As as appropriate.
25 Feb 2026
Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause		DraftThe purpose of this guidance is to describe considerations for generating substantial evidence of effectiveness and evidence of safety for individualized therapies based on a plausible mechanism framework. The plausible mechanism framework outlines a set of recommendations to help developers of individualized therapies generate sufficient clinical safety and efficacy data to demonstrate that a drug or biological product is safe and effective for the intended use, and that the product can be manufactured to regulatory quality standards. These data are used to support approval or licensure of an individualized therapy for a specific indication
6 Feb 2026E22 General Considerations for Patient Preference StudiesDraft, Level 1This harmonised ICH guideline outlines general considerations about the use, design, conduct, analysis, and submission of Patient preference studie (PPS) aimed at informing drug development, regulatory submission and evaluation, drug approvals and maintenance of such approvals.

This guideline focuses on methods called stated-preference methods. Stated-preference methods involve collecting preference data through surveys or interviews where participants are asked to express (state) their choices or acceptable thresholds for trade-offs for specific outcomes or treatment alternatives. Unlike revealed-preference methods, which rely on actual observed behaviour, stated-preference methods use hypothetical scenarios to understand how patients might behave under different conditions. Revealed-preference methods are outside the scope of this guideline.
3 Feb 2026Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions

Medical Devices		FinalThis guidance is applicable to devices with cybersecurity considerations, including but not limited to devices that include a device software function
or that contain software (including firmware) or programmable logic.

The guidance is not limited to devices that are network-enabled or contain
other connected capabilities.

This guidance describes recommendations regarding the
cybersecurity information to be submitted for devices under the following premarket submission types, when submitted to the Center for Devices and Radiological Health (CDRH) or the Center
for Biologics Evaluation and Research (CBER):
Premarket Notification (510(k)) submissions;
· De Novo requests;
· Premarket Approval Applications (PMAs) and PMA supplements;
· Product Development Protocols (PDPs);
· Investigational Device Exemption (IDE) submissions;
· Humanitarian Device Exemption (HDE) submissions;
· Biologics License Application (BLA) submissions; and
· Investigational New Drug (IND) submissions.
3 Feb 2026Computer Software Assurance for Production and Quality Management System Software

Medical Devices		FinalFDA is issuing this guidance to provide recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or
the quality management system.

This guidance:
i) Describes “computer software assurance” as a risk-based approach to establish confidence in the automation used for production or quality management systems, and identifies where additional rigor may be appropriate; and
ii) Describes various methods and testing activities that may be applied to establish
computer software assurance and provide objective evidence to fulfill regulatory requirements, such as computer software validation requirements in quality management
system obligations, including requirements in 21 CFR Part 820, which includes incorporations by reference of the 2016 edition of ISO 134852 (hereafter referred to as “Part 820”).
29 Jan 2026Clinical Decision Support SoftwareFinalThe purpose of this guidance is to describe FDA’s regulatory approach to CDS software functions. The Agency’s approach reflects changes to the FD&C Act made by the Cures Act, which amended section 520 and excludes certain software functions from the device definition. The focus of this guidance is to clarify the types of CDS software functions that are excluded from the definition of device by the criteria in section 520(o)(1)(E) of the FD&C Act. This guidance further clarifies that FDA’s existing digital health policies continue to apply to software functions that meet the definition of a device, including those that are intended for use by patients or caregivers. For example, some decision support software functions may be identified in other guidance documents as software functions for which, based on our current understanding of the risks of these software functions, FDA does not intend at this time to enforce compliance with applicable device requirements of the FD&C Act, including, but not limited to, premarket clearance and approval requirements.

This guidance provides many examples of how FDA intends to consider different kinds of software functions, including Non-Device CDS software functions and device software
functions.

21 Jan 2026M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: QualityDraft, Level 1The M4Q(R2) guideline establishes the location and structure of quality information for registration applications of all medicinal products for human use. It supports various submission types, including those referring to or consisting of master files, and applies to both initial marketing authorisation and post-approval submissions. This guideline is structured to be flexible to accommodate all types of medicinal products and their components.
12 Jan 2026Use of Bayesian Methodology in Clinical Trials of Drug and Biological ProductsDraftThis document provides guidance to sponsors and applicants submitting INDs, NDAs, BLAs, or supplemental applications on the appropriate use of Bayesian methods in clinical trials. Bayesian methods can be used in various ways in clinical trials. For example, Bayesian calculations can be used to govern the timing and adaptation rules for an interim analysis in an adaptive design, to inform design elements (e.g., dose selection) for subsequent clinical trials, or to support primary inference in a trial. The primary focus of this guidance is on the use of Bayesian methods to support primary inference in clinical trials intended to support the effectiveness and safety of drugs.
6 Jan 2026Clinical Decision Support Software

(Medical Devices) 		FinalThis guidance clarifies the scope of FDA’s oversight of clinical decision support software intended for health care professionals (HCPs) as devices. Not all clinical decision support software used in healthcare settings are devices and therefore subject to
FDA oversight as a device.

The purpose of this guidance is to describe FDA’s regulatory approach to CDS software
functions.