FDA 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 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US Federal Register - FDA Guidance Notices · United StatesFDA draft guidance on evaluating quality of container closure systems for drugs, biologics, and combination products.
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US Federal Register - FDA Guidance Notices · United StatesFDA announces draft guidance answering common questions on Forms 3542a and 3542 for applicants submitting to the Agency.
US Federal Register - FDA Guidance Notices · United StatesFDA announces draft guidance on designing, validating and evaluating potency assays for active immunotherapy products including peptide and protein-based ACTIMPs.
US Federal Register - FDA Guidance Notices · United StatesFDA announces draft guidance revising 2019 guidance on choosing between abbreviated and 505(b)(2) approval pathways for marketing applications.
US Federal Register - FDA Guidance Notices · United StatesFDA draft guidance on developing container closure systems and device constituent parts for biosimilar and interchangeable biosimilar products.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 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 announces final guidance harmonizing international genotoxicity testing requirements for veterinary drug residues in human food.
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US Federal Register - FDA Guidance Notices · United StatesRevised draft guidance on manufacturer communications of health care economic information about approved drugs and devices to payors and formulary committees.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 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 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 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 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 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 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 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 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 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 on washout periods and concomitant medication exclusions in cancer clinical trial eligibility criteria.
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 establishes FY 2027 establishment and reinspection fees for outsourcing facilities compounding human drugs.
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 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 final VICH guidance on study design for anthelmintic effectiveness in pigs to harmonise registration requirements.
US Federal Register - FDA Guidance Notices · United StatesFDA announces final VICH guidance on study design for anthelmintic effectiveness in horses to harmonise registration requirements.
US Federal Register - FDA Guidance Notices · United StatesFDA announces final guidance on study design for anthelmintic effectiveness in goats to harmonise veterinary medicinal product registration.
US Federal Register - FDA Guidance Notices · United StatesFDA announces final VICH guidance on study design for anthelmintic effectiveness in sheep to harmonise registration 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 finalizes guidance on statistical methods for bioequivalence studies in drug applications, replacing 2001 guidance.
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 guidance on study design and conduct for evaluating adhesion performance of transdermal and topical delivery systems in generic drug applications.
US Federal Register - FDA Guidance Notices · United StatesThe Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act...
US Federal Register - FDA Guidance Notices · United StatesFDA announces availability of revised draft product-specific guidances on bioequivalence study design for abbreviated new drug applications.
US Federal Register - FDA Guidance Notices · United StatesFDA finalizes guidance on in vivo pharmacodynamic bioequivalence demonstration for topical dermatologic corticosteroids in ANDA submissions.
US Federal Register - FDA Guidance Notices · United StatesThe Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act...
US Federal Register - FDA Guidance Notices · United StatesFDA announces final VICH guidance on study design for anthelmintic effectiveness in canine veterinary medicinal products.
US Federal Register - FDA Guidance Notices · United StatesFDA announces final guidance on study design for anthelmintic effectiveness in feline veterinary medicinal products.
US Federal Register - FDA Guidance Notices · United StatesFDA announces the FY 2027 annual fee rate for importers in the Voluntary Qualified Importer Program, effective August 1, 2026.
US Federal Register - FDA Guidance Notices · United StatesFDA announces user fee rates and payment procedures for animal drug applications, products, establishments and sponsors under ADUFA V for FY 2027.
US Federal Register - FDA Guidance Notices · United States