FDA announces draft guidance on premarket submission requirements for robotically-assisted surgical devices.
US Federal Register - FDA Guidance Notices · United StatesFDA announces final ICH guidance on harmonized digital clinical trial protocol standards, templates, and technical specifications for international regulatory exchange.
US Federal Register - FDA Guidance Notices · United StatesFDA announces support for forward compatibility of eCTD Version 4.0 for electronic submissions to CDER and CBER.
US Federal Register - FDA Guidance Notices · United StatesFDA will begin rejecting pharmaceutical and biologics submissions failing new eCTD v3.2.2 and v4.0 validation criteria effective 2024–2025.
US Federal Register - FDA Guidance Notices · United StatesFDA guidance establishes a risk-based framework for human factors information required in device marketing submissions to CDRH.
US Federal Register - FDA Guidance Notices · United StatesFDA guidance describing its intent to exempt certain unclassified medical devices from premarket notification requirements.
US Federal Register - FDA Guidance Notices · United StatesFDA announces draft guidance on electronic submission templates for PMAs to improve submission consistency and review efficiency.
US Federal Register - FDA Guidance Notices · United StatesFDA draft guidance on evaluating quality of container closure systems for drugs, biologics, and combination products.
US Federal Register - FDA Guidance Notices · United StatesFDA announces draft guidance on designing, validating and evaluating potency assays for active immunotherapy products including peptide and protein-based ACTIMPs.
US Federal Register - FDA Guidance Notices · United StatesFDA draft guidance on developing container closure systems and device constituent parts for biosimilar and interchangeable biosimilar products.
US Federal Register - FDA Guidance Notices · United StatesFDA announces draft guidance answering common questions on Forms 3542a and 3542 for applicants submitting to the Agency.
US Federal Register - FDA Guidance Notices · United StatesRevised draft guidance on manufacturer communications of health care economic information about approved drugs and devices to payors and formulary committees.
US Federal Register - FDA Guidance Notices · United StatesFDA finalizes ICH M15 guidance on model-informed drug development planning, evaluation, documentation, and regulatory submission.
US Federal Register - FDA Guidance Notices · United StatesFDA finalizes guidance on postapproval manufacturing changes to biosimilar and interchangeable biosimilar products licensed under the PHS Act.
US Federal Register - FDA Guidance Notices · United StatesFDA announces year five of the CMC Development and Readiness Pilot, facilitating expedited manufacturing development for IND products with accelerated clinical timelines.
US Federal Register - FDA Guidance Notices · United StatesThe Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federa...
US Federal Register - FDA Guidance Notices · United StatesFDA announces draft guidance revising 2019 guidance on choosing between abbreviated and 505(b)(2) approval pathways for marketing applications.
US Federal Register - FDA Guidance Notices · United StatesFDA finalizes guidance on development of cellular and gene therapy products, addressing regulatory, manufacturing, pharmacology, clinical and pharmacokinetic questions.
US Federal Register - FDA Guidance Notices · United StatesFDA guidance on Type VII Veterinary Master Files for research and development of animal cells, tissues, cell- and tissue-based products, gene therapies, and heritable genomic alterations in animals.
US Federal Register - FDA Guidance Notices · United StatesFDA requests public comment on clinical trial design elements for ibogaine drug products in opioid use disorder and PTSD studies.
US Federal Register - FDA Guidance Notices · United StatesFDA announces final guidance harmonizing international genotoxicity testing requirements for veterinary drug residues in human food.
US Federal Register - FDA Guidance Notices · United StatesFDA revises draft guidance on design, analysis and regulatory submission of master protocol trials for drug and biological product development.
US Federal Register - FDA Guidance Notices · United StatesFDA announces FY 2027 fee rates for domestic and foreign facility reinspections, recall compliance failures, and importer reinspections under FSMA.
US Federal Register - FDA Guidance Notices · United StatesFDA revises draft guidance on clinical evidence standards for drug effectiveness, clarifying reliance on one adequate and well-controlled investigation with confirmatory evidence.
US Federal Register - FDA Guidance Notices · United StatesFDA announces draft guidance on designing and analyzing pharmacokinetic studies in hepatically impaired patients, withdrawing the 2003 version.
US Federal Register - FDA Guidance Notices · United StatesFDA revises draft guidance on in vivo skin irritation and sensitization study design and conduct for transdermal and topical delivery systems in ANDAs.
US Federal Register - FDA Guidance Notices · United StatesFDA finalizes guidance on selecting laboratory values as cancer trial eligibility criteria to avoid unjustified participant exclusions.
US Federal Register - FDA Guidance Notices · United StatesFDA finalizes guidance recommending expansion of cancer clinical trial eligibility criteria to include patients with wider range of performance status.
US Federal Register - FDA Guidance Notices · United StatesFDA finalizes guidance on washout periods and concomitant medication exclusions in cancer clinical trial eligibility criteria.
US Federal Register - FDA Guidance Notices · United StatesFDA invites public comment on proposed recommendations for PDUFA reauthorization for fiscal years 2028–2032 before current authority expires September 2027.
US Federal Register - FDA Guidance Notices · United StatesFDA announces draft guidance on target animal safety evaluation methods for veterinary monoclonal antibody products, harmonized internationally via VICH.
US Federal Register - FDA Guidance Notices · United StatesFDA guidance on regulatory priorities for compounding starter parenteral nutrition products for neonates by outsourcing facilities and State-licensed pharmacies.
US Federal Register - FDA Guidance Notices · United StatesFDA announces final guidance on harmonised reproduction testing protocols for evaluating safety of veterinary drug residues in food.
US Federal Register - FDA Guidance Notices · United StatesFDA guidance on evaluating microbiological effects of antimicrobial new animal drugs on human-health-concern bacteria in new animal drug applications.
US Federal Register - FDA Guidance Notices · United StatesFDA establishes FY 2027 establishment and reinspection fees for outsourcing facilities compounding human drugs.
US Federal Register - FDA Guidance Notices · United StatesFDA finalizes guidance on clinical trial design and conduct for psychedelic drug development in psychiatric and substance use disorder treatment.
US Federal Register - FDA Guidance Notices · United StatesFDA draft guidance on applying quantitative systems pharmacology modeling to determine starting doses in first-in-human trials for drugs and biologics.
US Federal Register - FDA Guidance Notices · United StatesFDA draft guidance on leveraging prior knowledge in development of human gene therapy products with ex vivo and in vivo genome editing.
US Federal Register - FDA Guidance Notices · United StatesFDA announces draft guidance on compounding animal drug products from bulk drug substances under CGMP at registered facilities.
US Federal Register - FDA Guidance Notices · United StatesFDA invites 60-day public comment on proposed information collection for third-party disclosure and recordkeeping requirements for reportable food.
US Federal Register - FDA Guidance Notices · United StatesFDA finalizes guidance on statistical methods for bioequivalence studies in drug applications, replacing 2001 guidance.
US Federal Register - FDA Guidance Notices · United StatesFDA seeks public comment on information collection requirements for guidance on handling commodities with pesticide residues where EPA has revoked, suspended, or modified tolerances.
US Federal Register - FDA Guidance Notices · United StatesFDA draft guidance on streamlined nonclinical toxicology study approaches for oncology biologics and conjugated products to reduce animal use.
US Federal Register - FDA Guidance Notices · United StatesFDA finalizes guidance on bioequivalence study requirements for generic drug applications under the ANDA pathway.
US Federal Register - FDA Guidance Notices · United StatesFDA finalizes guidance on procedures and principles for formal meetings between the Agency and OTC monograph drug sponsors or requestors.
US Federal Register - FDA Guidance Notices · United StatesFDA solicits stakeholder input on botanical drug product development, challenges, and regulatory information-gathering requirements.
US Federal Register - FDA Guidance Notices · United StatesFDA announces final VICH guidance on study design for anthelmintic effectiveness in cattle to harmonise registration requirements.
US Federal Register - FDA Guidance Notices · United StatesFDA announces final guidance on study design for anthelmintic effectiveness data to harmonise veterinary medicinal product registration requirements.
US Federal Register - FDA Guidance Notices · United StatesFDA announces final guidance on study design for anthelmintic effectiveness in chickens to harmonise veterinary medicinal product registration requirements.
US Federal Register - FDA Guidance Notices · United StatesFDA announces final VICH guidance on study design for anthelmintic effectiveness in pigs to harmonise registration requirements.
US Federal Register - FDA Guidance Notices · United States