US Federal Register - FDA Guidance Notices is an official public source that HealthSignal monitors for Pharmaceuticals, Medical Devices & IVD. The most recent updates we have tracked from it are listed below, each normalised into our index and linked back to the original publication on the source's own website.
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 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US Federal Register - FDA Guidance Notices · United StatesFDA announces draft guidance answering common questions on Forms 3542a and 3542 for applicants submitting to the Agency.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 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US Federal Register - FDA Guidance Notices · United StatesRevised draft guidance on manufacturer communications of health care economic information about approved drugs and devices to payors and formulary committees.
US Federal Register - FDA Guidance Notices · United StatesFDA draft guidance on developing container closure systems and device constituent parts for biosimilar and interchangeable biosimilar products.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 clinical trial design and conduct for psychedelic drug development in psychiatric and substance use disorder treatment.
US Federal Register - FDA Guidance Notices · United StatesFDA revises draft guidance on design, analysis and regulatory submission of master protocol trials for drug and biological product development.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US Federal Register - FDA Guidance Notices · United StatesFDA revises draft guidance on clinical evidence standards for drug effectiveness, clarifying reliance on one adequate and well-controlled investigation with confirmatory evidence.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 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 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 finalizes guidance on selecting laboratory values as cancer trial eligibility criteria to avoid unjustified participant exclusions.
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 procedures and principles for formal meetings between the Agency and OTC monograph drug sponsors or requestors.
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 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 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 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 data 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 sheep 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 pigs 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 in chickens to harmonise veterinary medicinal product registration requirements.
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 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 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 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 availability of draft product-specific guidances on bioequivalence study design for abbreviated new drug applications.
US Federal Register - FDA Guidance Notices · United StatesFDA guidance on designing, conducting and reporting PER rat bioassay studies to demonstrate infant formula protein quality.
US Federal Register - FDA Guidance Notices · United StatesFDA declines to designate hepatitis delta virus infection as a tropical disease under Section 524 of the FD&C Act.
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 final VICH guidance on study design for anthelmintic effectiveness in canine veterinary medicinal products.
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 withdraws approval of ANDA 202608 for methylphenidate HCl ER tablets at three strengths held by SpecGx LLC.
US Federal Register - FDA Guidance Notices · United States