Proposed amendments to CLIA regulations to permit virtual access for laboratory testing data, digital images for cytology proficiency testing, and updated personnel and reporting requirements.
US Federal Register - CMS Rules · United StatesFDA announces draft guidance on premarket submission requirements for robotically-assisted surgical devices.
US Federal Register - FDA Guidance Notices · United StatesCMS proposes a faster pathway for manufacturers to obtain Medicare coverage of new medical devices.
US CMS Newsroom · United StatesDEA and HHS extend telemedicine flexibilities for controlled-medication prescribing through December 31, 2026.
US Federal Register - DEA Telehealth Rules · 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 StatesFinal rules amend price transparency requirements for non-grandfathered group and individual health plans, standardizing machine-readable pricing files with new data elements and reporting thresholds.
US Federal Register - HHS Rules · United StatesProposed requirements for electronic prior authorization for drugs and extended interoperability standards across Medicare Advantage, Medicaid, CHIP, and QHP issuers.
US Federal Register - CMS Rules · 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 announces medical device user fee rates and payment procedures for FY 2027 (October 1, 2026 – September 30, 2027) under MDUFA V.
US Federal Register - FDA Notices · United StatesDEA establishes Special Registration framework for telemedicine practitioners to prescribe controlled substances without in-person evaluation, with heightened recordkeeping and reporting requirements.
US Federal Register - DEA Telehealth Rules · United StatesDEA extends telemedicine flexibilities for controlled-medication prescribing through December 31, 2025.
US Federal Register - DEA Telehealth Rules · United StatesFDA guidance describing its intent to exempt certain unclassified medical devices from premarket notification requirements.
US Federal Register - FDA Guidance Notices · United StatesFDA CDER requests feedback on developing a cross-sector collaborative platform to advance quantitative medicine approaches in drug development and regulatory science.
US Federal Register - FDA Notices · United StatesDEA finalizes rules preventing illegal distribution of controlled substances via internet, including telehealth prescribing restrictions and identity verification requirements.
US Federal Register - DEA Telehealth Rules · United StatesDEA issues interim rule amending regulations to implement the Ryan Haight Act's provisions preventing illegal distribution of controlled substances via the Internet.
US Federal Register - DEA Telehealth Rules · 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 announces advisory committee meeting and opens public docket to solicit input on pathogen-agnostic sequencing for emergency preparedness and response.
US Federal Register - FDA Notices · United StatesDEA and HHS postponed the effective dates of final rules expanding buprenorphine telemedicine treatment and VA continuity-of-care telemedicine from March 21 to a later date pending further review.
US Federal Register - DEA Telehealth Rules · United StatesDEA and HHS delayed the effective date of two final rules on buprenorphine telemedicine and VA continuity of care from February 18 to March 21, 2025.
US Federal Register - DEA Telehealth Rules · United StatesDEA and HHS amend regulations to permit audio-only telemedicine prescribing of schedule III-V controlled substances for opioid use disorder after PDMP review.
US Federal Register - DEA Telehealth Rules · United StatesDEA extends temporary exceptions allowing telemedicine prescribing of controlled medications without prior in-person evaluation beyond November 11, 2023.
US Federal Register - DEA Telehealth Rules · United StatesDEA extends temporary exceptions to controlled-medication prescribing rules to permit telemedicine without prior in-person evaluation pending final rulemaking.
US Federal Register - DEA Telehealth Rules · United StatesDEA proposes rule permitting telehealth prescribing of controlled medications without prior in-person evaluation in limited circumstances.
US Federal Register - DEA Telehealth Rules · United StatesFDA draft guidance on evaluating quality of container closure systems for drugs, biologics, and combination products.
US Federal Register - FDA Guidance Notices · United StatesCMS revises IPPS and LTCH payment rates for FY 2027, updates quality program requirements, and ONC adopts updated health IT standards.
US Federal Register - CMS Rules · 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 StatesVA practitioners may prescribe controlled substances via telemedicine to VA patients without prior in-person evaluation if another VA practitioner previously evaluated the patient.
US Federal Register - DEA Telehealth Rules · United StatesDEA amends regulations to expand authorization for practitioners to prescribe schedule III-V narcotic drugs for maintenance or withdrawal management via telemedicine, including audio-only encounters.
US Federal Register - DEA Telehealth Rules · United StatesDEA permits mobile components of registered narcotic treatment programs to dispense controlled substances at remote locations without separate registration.
US Federal Register - DEA Telehealth Rules · 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 StatesHHS solicits input on regulatory pathways for deceased donor islet cell therapies for Type 1 diabetes treatment.
US Federal Register - FDA Notices · United StatesCMS and CDC seek public input on updating CLIA regulations covering breath testing, laboratory processes, emergency preparedness, biosafety, biosecurity, and cybersecurity.
US Federal Register - CMS Rules · United StatesFDA classifies diabetes digital behavioral therapeutic devices into class II with special controls to ensure safety and effectiveness.
US Federal Register - FDA Rules · United StatesFinal rule implements SUPPORT Act amendments to expand practitioner qualifications and pharmacy delivery options for opioid-use-disorder medication-assisted treatment via telehealth.
US Federal Register - DEA Telehealth Rules · United StatesFDA denied a petition for exemption from premarket notification requirements for radiology computer-aided detection, diagnosis, and triage software devices.
US Federal Register - FDA Rules · United StatesFDA classifies high throughput DNA sequencing for hereditary cancer predisposition assessment test systems into class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies nucleic acid detection systems for non-viral STI pathogens from home-collected specimens into class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies focused ultrasound systems for non-thermal mechanical tissue ablation into Class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies hyperoxia monitoring device adjunct to pulse oximetry as Class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies cardiovascular machine learning-based notification software as Class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies hematopoietic cell enrichment kit as Class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies infant pulse rate and oxygen saturation monitor for over-the-counter use into class II with special controls.
US Federal Register - FDA Rules · United StatesFDA exempts certain Class II clinical toxicology test systems from 510(k) premarket notification requirements, effective immediately.
US Federal Register - FDA Rules · United StatesFDA classifies flushing and storage solution for vascular autografts at room temperature as Class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies the cooperative powered surgical assist device for ENT surgery into class II with special controls.
US Federal Register - FDA Rules · United States