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FDA Updated Guidance

September 2026

  • Robotically-Assisted Surgical Devices - Premarket Submissions

    Robotically-Assisted Surgical Devices - Premarket Submissions

    September 25, 2026

    The Food and Drug Administration has issued the draft guidance Robotically-Assisted Surgical Devices - Premarket Submissions, which provides recommendations for premarket submissions for certain robotically-assisted surgical devices (RASDs). The guidance addresses FDA's expectations for device description, performance testing, software validation, cybersecurity, human factors, clinical evidence, training, and labeling. FDA notes that the recommendations are intended to support consistent submission quality and facilitate efficient review of these increasingly complex surgical technologies.

    The draft guidance may be of interest to device developers, biomedical engineers, surgical innovators, and researchers involved in the development or evaluation of robotically-assisted surgical platforms. The document reflects FDA's current thinking on the evidence needed to demonstrate the safety and effectiveness of these systems and may help guide development and regulatory planning for future surgical technologies.

    Source Documents
    1. FDA Guidance Page: Robotically-Assisted - Surgical Devices - Premarket Submissions
    2. Federal Register Notice: Robotically-Assisted Surgical Devices-Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
    3. Draft Guidance Document (September 25, 2026)
    Public Comment Information
    FDA is accepting comments on the draft guidance through November 24, 2026. Comments may be submitted electronically through Regulations.gov under Docket No. FDA-2026-N-9505 or by written submission to FDA's Dockets Management Staff. FDA notes that electronically submitted comments will be posted publicly.
  • Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Program Announcement

    Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Program Announcement

    September 21, 2026

    The Food and Drug Administration has announced Year 5 of the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP), a program intended to facilitate the development of drugs and biologics with accelerated clinical development timelines. Through the pilot, FDA provides enhanced communication and engagement opportunities to help sponsors address chemistry, manufacturing, and controls challenges that can affect product development and regulatory readiness. The program is available to eligible products regulated by both FDA's drug and biologics centers and is intended to support earlier patient access to promising therapies for serious conditions with unmet medical needs.

    Beginning October 1, 2026, eligible sponsors may submit requests to participate in the pilot. Selected participants receive additional opportunities for interaction with FDA review teams, including CMC-focused meetings and discussions intended to facilitate efficient product development and preparation for future marketing applications. The pilot is part of FDA's broader efforts under PDUFA VII to support products in expedited development programs.

    Source Documents
    1. Federal Register Notice: Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Program Announcement

    2. FDA CDRP Program Information: Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program

  • BsUFA III Future Needs in the Development of Interchangeable Products Post-Workshop Strategy Document

    BsUFA III Future Needs in the Development of Interchangeable Products Post-Workshop Strategy Document

    September 18, 2026

    This document outlines FDA's future priorities for supporting the development of interchangeable biosimilar products. The draft document summarizes discussions from FDA's September 2025 public workshop on advancing interchangeable products and fulfills a commitment under the Biosimilar User Fee Act III (BsUFA III) reauthorization program. FDA indicates that future efforts will focus on scientific and regulatory issues affecting interchangeable biosimilars, including analytical considerations, human factors, stakeholder education, and approaches that may facilitate development and patient access. The draft strategy is intended to inform future FDA activities and does not establish new regulatory requirements. Because biosimilars are widely used across multiple therapeutic areas, the document may be of interest to researchers, clinicians, pharmacists, health-system leaders, and stakeholders involved in biologic drug development, evaluation, and utilization. FDA is accepting public comments before finalizing the strategy document.

    Source Documents
    1.Federal Register Notice: Biosimilar User Fee Act III Future Needs in the Development of Interchangeable Products Post-Workshop; Draft Strategy Document
    2.Draft Strategy Document (referenced in the notice): Available through the FDA docket associated with Docket No. FDA-2025-N-2787. Instructions for Public Comment FDA is accepting electronic comments through November 17, 2026 via Regulations.gov under Docket No. FDA-2025-N-2787. Comments submitted electronically will be posted publicly; confidential information should not be included in electronic submissions. Written comments may also be submitted as described in the Federal Register notice.
  • Statistical Considerations for the Design of Rare Disease Clinical Investigations; Establishment of a Public Docket; Request for Information and Comments

    Statistical Considerations for the Design of Rare Disease Clinical Investigations; Establishment of a Public Docket; Request for Information and Comments

    September 15, 2026

    The Food and Drug Administration has established a public docket to gather stakeholder feedback on statistical considerations in rare disease clinical investigations. The request for information accompanies FDA's Rare Disease Innovation, Science, and Exploration (RISE) workshop, which focuses on challenges associated with designing, conducting, and analyzing clinical trials in small patient populations. FDA is seeking input on approaches that can improve trial efficiency while maintaining scientific rigor and producing reliable evidence to support medical product development for rare diseases. Topics of interest include the role of randomization and blinding, strategies to enhance study efficiency, statistical methods for small populations, and considerations relevant to drugs, biologics, and medical devices intended for rare disease populations. FDA plans to use stakeholder feedback to inform future rare disease development initiatives and regulatory approaches. The notice may be of particular interest to investigators conducting rare disease research, biostatisticians, clinical trial designers, patient advocacy organizations, and sponsors developing therapies for orphan indications.

    Source Documents
    1.Federal Register Notice: Statistical Considerations for the Design of Rare Disease Clinical Investigations; Establishment of a Public Docket; Request for Information and Comments.
    2.FDA Workshop: RISE to the Challenge: Statistical Considerations for Rare Disease Clinical Investigations

    Public Comment Information
    FDA is accepting comments through November 13, 2026 under Docket No. FDA-2026-N-10165. Comments may be submitted electronically through Regulations.gov or by written submission as described in the Federal Register notice. Electronic comments must be received by 11:59 p.m. Eastern Time on November 13, 2026 to be considered. Commenters should not include confidential information in electronic submissions because comments will be posted publicly.
  • Advancing Development of Botanical Drug Products; Request for Information

    Advancing Development of Botanical Drug Products; Request for Information

    September 4, 2026

    The FDA announces the establishment of a public docket to gather input on how to advance the development of botanical drug products in the United States. FDA notes that botanical drug products, which may be derived from plants, algae, fungi, or combinations thereof, present unique scientific and regulatory challenges due to their complexity and variability. The agency is seeking feedback from researchers, clinicians, industry, patients, and other stakeholders regarding current barriers to development and potential approaches to improve the generation of evidence needed to support safety and effectiveness under the Federal Food, Drug, and Cosmetic Act. FDA intends to use this information to inform future policy, scientific initiatives, and stakeholder engagement efforts related to botanical drug development.

    FDA is specifically interested in comments regarding scientific, manufacturing, quality-control, clinical development, and regulatory issues that may impede the development of botanical drug products. The notice does not propose new regulatory requirements; rather, it is an information-gathering effort designed to better understand stakeholder experiences and identify opportunities to accelerate the development of safe and effective botanical therapies. FDA notes that only a small number of botanical products have been approved through the prescription drug pathway to date, highlighting the need for additional dialogue and research in this area.

    Source Documents
    1.Federal Register Notice Advancing Development of Botanical Drug Products; Request for Information
    2.FDA Announcement: FDA Seeks Public Input to Advance Development of Botanical Drug Products
    3.FDA Botanical Drug Products Resource Page Botanical Drug Products

    Instructions for Public Comment
    Comments may be submitted electronically through the Federal eRulemaking Portal at www.regulations.gov under Docket No. FDA-2026-N-9550. Written comments may also be submitted by mail or hand delivery as described in the Federal Register notice. FDA will accept comments through November 3, 2026, and electronic submissions must be received by 11:59 p.m. Eastern Time on that date to be considered. Commenters should not include confidential information in submissions made through Regulations.gov because all comments will be posted publicly.
  • Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling

    Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling

    September 2, 2026

    The Food and Drug Administration has issued the draft guidance Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling. The guidance provides recommendations for assessing the effects of hepatic impairment on the pharmacokinetics and, when appropriate, pharmacodynamics of drugs and therapeutic biologic products. It addresses considerations for determining when dedicated hepatic impairment studies are needed, study design and conduct, classification of liver dysfunction, data analysis approaches, and the incorporation of study findings into dosing recommendations and product labeling.

    According to FDA, the draft guidance is intended to replace the agency's 2003 guidance on hepatic impairment studies and reflects current scientific and regulatory approaches to evaluating drug exposure in patients with compromised liver function. The guidance may be particularly relevant to investigators developing new therapeutics, conducting clinical pharmacology studies, or designing trials that include patients with hepatic impairment.

    Source Documents
    1.Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling
    2.Federal Register Notice of Availability

    Public Comment Information
    FDA is accepting comments on the draft guidance through December 1, 2026. Comments may be submitted electronically through Regulations.gov and should reference Docket No. FDA-2026-D-8693. Written comments may also be submitted to FDA's Dockets Management Staff. FDA notes that electronically submitted comments will be posted publicly.

August 2026

  • Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products

    Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products

    August 2026

    The FDA’s Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products provides recommendations for formal interactions between FDA and sponsors developing human drugs and biologics regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The guidance outlines the various meeting types available throughout product development, including Type A, B, B(EOP), C, D, and INTERACT meetings, and describes the procedures for requesting meetings, preparing meeting packages, conducting meetings, obtaining FDA feedback, and documenting outcomes. The goal is to promote timely, consistent, and effective communication between FDA and sponsors at key development milestones.

    The guidance is particularly important for sponsor-investigators and academic researchers developing investigational drugs, biologics, cell and gene therapies, and other FDA-regulated products. It emphasizes the value of early FDA engagement through mechanisms such as pre-IND and INTERACT meetings, helping sponsors obtain regulatory input on clinical, nonclinical, manufacturing, and product development issues before submitting major regulatory applications. The guidance also establishes procedural timelines and expectations that can help researchers efficiently navigate FDA interactions and advance product development programs.

    Source: FDA Guidance for Industry, Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products (August 2026)

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  • Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products

    Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products

    August 2026

    This guidance provides FDA’s current recommendations and answers to common questions that arise during the development of cellular and gene therapy (CGT) products. The guidance covers the full development lifecycle, including IND submissions and FDA interactions, chemistry, manufacturing, and controls (CMC), nonclinical testing, clinical trial design, expedited programs, and preparation for biologics license applications (BLAs). Its goal is to help sponsors develop safe, effective, and high-quality CGT products while better understanding FDA’s expectations and review processes.

    For clinical researchers and sponsors, the guidance is particularly useful because it consolidates FDA’s recommendations on topics such as product characterization, manufacturing changes, proof-of-concept and toxicology studies, biodistribution testing, endpoint selection, and long-term safety monitoring. While focused on CGT products, it provides practical insight into regulatory expectations that can inform investigator-sponsored and industry-sponsored development programs alike. Source Guidance: FDA, Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products (Guidance for Industry, August 2026)

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  • Potency Assessment of Active Immunotherapy Products

    Potency Assessment of Active Immunotherapy Products

    August 19, 2026

    This document provides FDA recommendations for designing, validating, and evaluating potency assays used to assess active immunotherapy products (ACTIMPs). These products work by inducing, stimulating, or modulating immune responses against an existing disease and include certain peptide-, protein-, vector-, and cell-based immunotherapies. The guidance focuses on developing potency-testing strategies that demonstrate product quality and consistency throughout development and manufacturing.

    For the UAB research community, this guidance is particularly relevant to investigators developing cancer immunotherapies, therapeutic vaccines, personalized neoantigen therapies, cell-based immunotherapies, and other immune-modulating biologic products under FDA oversight. It may affect researchers holding INDs, working with GMP-manufactured immunotherapy products, or planning translational studies that could ultimately support product licensure. Researchers conducting conventional drug trials, observational studies, or non-immunotherapy research would be less directly affected.

    Bottom line for UAB: This guidance is highly relevant to UAB's immunology, oncology, cell therapy, gene therapy, and translational medicine programs because it outlines FDA's expectations for demonstrating potency, a critical component of product quality and regulatory approval for active immunotherapies.

    Source Document: Potency Assessment of Active Immunotherapy Products (Draft Guidance for Industry, August 19, 2026)

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  • Applying Human Factors and Usability Engineering to Medical Devices

    Applying Human Factors and Usability Engineering to Medical Devices

    August 3, 2026

    Applying Human Factors and Usability Engineering to Medical Devices explains FDA’s expectations for incorporating human factors and usability engineering into the design and development of medical devices. The guidance is intended to help manufacturers and device developers identify, evaluate, and mitigate use-related risks by considering how intended users interact with a device, its labeling, software, controls, displays, training materials, and use environment. FDA emphasizes that device design should minimize use errors that could result in patient harm or compromised medical care and recommends a risk-based approach that includes user research, task analyses, identification of critical tasks, usability testing, and human factors validation testing.

    The guidance is most relevant to organizations developing or modifying medical devices for FDA submission, including products regulated through IDE, 510(k), De Novo, or PMA pathways. FDA recommends that human factors activities be integrated into the device development and risk management process and that human factors validation testing be used to demonstrate that intended users can safely and effectively use the device under expected real-world conditions. While the guidance is nonbinding, it reflects FDA’s current thinking and is frequently referenced during device review.

    For more information: FDA, Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff (originally issued February 3, 2016; current version updated August 3, 2026)

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July 2026

  • FDA Issues Final Guidance on Laboratory Value Eligibility Criteria for Cancer Clinical Trials

    FDA Issues Final Guidance on Laboratory Value Eligibility Criteria for Cancer Clinical Trials

    July 2026

    The FDA Oncology Center of Excellence (OCE), Center for Drug Evaluation and Research (CDER), and Center for Biologics Evaluation and Research (CBER) issued the final guidance, Cancer Clinical Trial Eligibility Criteria: Laboratory Values. The guidance recommends that laboratory-based eligibility criteria in cancer clinical trials be scientifically justified and tailored to the investigational product and study population, rather than relying on historically accepted thresholds. FDA notes that overly restrictive laboratory requirements may unnecessarily exclude patients, slow enrollment, and limit the generalizability of trial results.

    The guidance encourages sponsors to routinely reassess laboratory exclusion criteria, consider expected variations in laboratory values, and use evidence-based thresholds that appropriately balance patient safety with broader trial participation. The recommendations are intended to support more representative enrollment while maintaining adequate safety protections, particularly in later-phase oncology trials.

    Relevance to UAB: This guidance is relevant to investigators and sponsors conducting oncology clinical trials, particularly those designing or reviewing eligibility criteria for IND studies. It may also be useful to IRBs, protocol development teams, and regulatory personnel involved in cancer clinical trial design.
  • Submitting Next-Generation Sequencing Data to the Division of Antiviral Products

    Submitting Next-Generation Sequencing Data to the Division of Antiviral Products

    July 2026

    This is a technical FDA guidance that describes how sponsors should submit next-generation sequencing (NGS) protocols, datasets, and analyses to support antiviral drug resistance assessments during drug development. The guidance specifies expectations for NGS methods, raw sequencing data, bioinformatics analyses, resistance reporting, and data formats so that FDA can independently evaluate antiviral resistance findings.

    For the UAB research community, this guidance is most relevant to investigators conducting antiviral drug development, including studies involving HIV, hepatitis viruses, respiratory viruses, emerging infectious diseases, or other viral pathogens where genomic sequencing is used to evaluate resistance. It may also be important for researchers holding INDs, collaborating with industry sponsors, or generating sequencing data intended to support FDA regulatory submissions. Researchers using NGS solely for basic science, observational research, diagnostics, or non-antiviral clinical studies would generally be less affected.

    Source Document: FDA, Submitting Next-Generation Sequencing Data to the Division of Antiviral Products (July 2026)

    FDA Guidance Page: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submitting-next-generation-sequencing-data-division-antiviral-products
  • FDA Finalizes Guidance on Performance Status Eligibility Criteria for Cancer Clinical Trials

    FDA Finalizes Guidance on Performance Status Eligibility Criteria for Cancer Clinical Trials

    July 28, 2026

    The FDA announced the availability of the final guidance, Cancer Clinical Trial Eligibility Criteria: Performance Status. The guidance recommends that sponsors carefully evaluate whether traditional performance status (PS) restrictions are scientifically necessary and encourages consideration of including patients with a broader range of performance status when appropriate. FDA notes that unnecessarily restrictive PS criteria can limit trial access, slow enrollment, and reduce the applicability of study results to the patients who will ultimately use the therapy in clinical practice.

    The guidance encourages the use of evidence-based eligibility criteria, consideration of alternative trial designs, and additional assessments of functional status where appropriate. The goal is to improve the representativeness and generalizability of oncology clinical trial populations while maintaining participant safety and adequate evaluation of benefit-risk.

    Relevance to UAB: This guidance is relevant to investigators, sponsors, protocol development teams, and IRBs involved in oncology clinical trials. It may affect the design and justification of eligibility criteria for cancer studies conducted under INDs and encourages enrollment practices that better reflect real-world patient populations.
  • FDA Finalizes Guidance on Washout Periods and Concomitant Medications in Cancer Clinical Trials

    FDA Finalizes Guidance on Washout Periods and Concomitant Medications in Cancer Clinical Trials

    July 28, 2026

    The FDA issued the final guidance, Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications. The guidance recommends that washout periods and restrictions on concomitant medications be scientifically justified and tailored to the investigational product, rather than relying on standardized or historically accepted requirements. FDA notes that unnecessarily long washout periods and overly restrictive medication exclusions may delay enrollment, limit patient participation, and reduce the representativeness of trial populations.

    The guidance encourages sponsors to use risk-based approaches when determining washout requirements and to allow concomitant medications whenever they do not meaningfully affect patient safety or trial interpretation. The recommendations are intended to broaden access to oncology clinical trials while maintaining participant safety and data integrity, supporting enrollment of patient populations that more closely reflect real-world clinical practice.

    Relevance to UAB: This guidance is relevant to oncology investigators, sponsors, protocol development teams, and IRBs involved in cancer clinical trials. The recommendations may affect protocol design, eligibility criteria, and regulatory review of oncology studies conducted under INDs by encouraging evidence-based justification for washout periods and medication exclusions.

June 2026

  • FDA Revises Guidance on Demonstrating Clinical Trial Effectiveness: Opportunities for Single-Trial Approvals

    FDA Revises Guidance on Demonstrating Clinical Trial Effectiveness: Opportunities for Single-Trial Approvals

    June 2026

    The FDA has issued an important revised draft guidance, Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products, which modernizes the agency's flexibility in evaluating drug and biologic efficacy. While the traditional regulatory benchmark historically required two independent, well-controlled clinical trials, this updated framework formalizes the pathway for a single, highly persuasive clinical investigation supported by robust confirmatory evidence.

    This update is highly advantageous for UAB sponsor-investigators, particularly those working in rare diseases or specialized oncology pipelines, as it explicitly outlines how researchers can leverage external data sources, such as institutional natural history studies, real-world evidence (RWE), and data from related disease mechanisms, to meet FDA approval standards with a more streamlined trial blueprint.

    Because relying on a single trial requires exceptional study power, generalizability, and minimal missing data, the FDA strongly emphasizes that academic sponsors must engage the agency early in the design process, no later than the End-of-Phase 2 meeting. UAB investigators planning upcoming clinical drug or biologic protocols are highly encouraged to review the new standards to optimize their translation timelines and regulatory strategies.
  • Master Protocols for Drug and Biological Product Development

    Master Protocols for Drug and Biological Product Development

    June 2026

    The FDA draft guidance Master Protocols for Drug and Biological Product Development (June 2026) provides recommendations on the design, conduct, statistical analysis, and regulatory submission requirements for clinical trials conducted under a master protocol, where multiple treatments, diseases, or patient populations are studied within a single overarching trial structure. FDA's focus is on randomized trials intended to generate evidence of safety and effectiveness to support regulatory decision-making.

    For UAB researchers, the guidance is most applicable to investigators conducting complex oncology, precision medicine, rare disease, and other multi-site clinical trials, especially those sponsored through cooperative groups, NIH networks, or investigator-held INDs. It may influence trial design, statistical planning, informed consent approaches, data monitoring, and FDA interactions.

    Source Document: FDA, Master Protocols for Drug and Biological Product Development (Draft Guidance for Industry, June 2026)
  • Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials

    Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials

    June 2026

    This update provides FDA recommendations on using quantitative systems pharmacology (QSP) modeling to determine safe starting doses for first-in-human studies. The guidance focuses on products where the MABEL approach is appropriate, particularly novel drugs and biologics that may produce potent biological effects such as cytokine release, T-cell activation, or other significant pharmacologic responses.

    For the UAB research community, this guidance is most relevant to investigators conducting early-phase translational research, especially those developing biologics, immunotherapies, cell and gene therapies, or other novel therapeutics under investigator-sponsored INDs.

    Bottom line for UAB: This guidance is especially relevant to translational scientists and IND sponsors developing innovative therapeutics, as it describes how QSP modeling can support the selection of safe and scientifically justified starting doses in first-in-human trials.

    Source Document: Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials (Draft Guidance for Industry, June 2026)
  • FDA Finalizes ICH M15 Guidance on Model-Informed Drug Development

    FDA Finalizes ICH M15 Guidance on Model-Informed Drug Development

    June 3, 2026

    The FDA issued the final ICH M15: General Principles for Model-Informed Drug Development guidance, establishing a harmonized framework for the planning, evaluation, documentation, and regulatory use of model-informed drug development (MIDD) approaches.

    The guidance is relevant to clinical and translational research programs that utilize pharmacokinetic/pharmacodynamic modeling, exposure-response analyses, disease progression models, clinical trial simulations, or other quantitative methods to inform study design, dose selection, and evidence generation.

May 2026