Healthcare & Life Sciences

FDA Defaults to Single Pivotal Trial for Drug Approvals

FDA Commissioner Martin Makary and CBER Director Vinay Prasad announced FDA's new default standard requiring only one pivotal trial for drug approvals instead of two. The agency also released draft guidance establishing a Plausible Mechanism Framework for individualized gene-editing and RNA-based therapies targeting rare genetic conditions. Drug sponsors should note potential increased post-market data collection obligations under the new framework.

HHS OIG Provides Succession Planning Roadmap for ASCs

HHS OIG issued Advisory Opinion 26-04 concluding it would not impose administrative sanctions under the Anti-Kickback Statute for a physician's proposed transfer of ownership interests in an ambulatory surgery center (ASC) as part of estate and succession planning. Despite the arrangement's failure to satisfy every element of the ASC investment safe harbor, the OIG determined the proposal presented sufficiently low fraud and abuse risk due to fair market value pricing, proportional profit distributions, and absence of referral-related conditions.

New York Requires Employers to Stock Opioid Antagonists

New York enacted NY Labor Law § 27-f, requiring private employers already mandated by OSHA standards to maintain first aid kits to also stock opioid antagonists (naloxone). Governor Hochul signed the amended bill on February 13, 2026, with the law taking effect December 13, 2026. The NY State Department of Labor must issue regulations addressing workplace training and required quantities.

DOJ's Bulk Sensitive Data Transfer Rule: Key Insights for Health Care Compliance

Epstein Becker Green analyzes the U.S. Department of Justice's Bulk Sensitive Data (BSD) Transfer Rule, which imposes compliance obligations on healthcare and life sciences organizations that transfer or provide access to sensitive data, including genomic information. The rule applies when data on as few as 100 individuals is shared, catching many organizations unprepared. The BSD Transfer Rule creates obligations that extend beyond HIPAA, applying even to de-identified or anonymized data, and covers any access by foreign vendors, board members, or investors—not only formal data-sharing agreements.

Hospices Face Increased Scrutiny Under New CMS Scoring

CMS has proposed a new Service and Spending Variation Index (SSVI) scoring system for hospice providers to be implemented in fiscal year 2027. The system will track metrics including non-hospice spending, length of stay, live discharge return rates, and average minutes per routine home care day. Facility SSVI scores will be publicly posted on the CMS Hospice Center webpage, with high scores triggering increased oversight, additional reviews, and potential license revocations.

FDA Regulatory Burdens for Mid-Sized Pharma Under 100% Drug Tariffs

Maynard Nexsen published analysis on April 16, 2026 examining how mid-sized branded pharmaceutical companies and specialty biotech face significant FDA regulatory obligations when attempting to relocate manufacturing to mitigate the 100% drug tariffs announced by President Trump on April 2, 2026. The article explains that moving drug substance, drug product, fill-finish, or packaging operations to new facilities triggers FDA postapproval change requirements, including Prior Approval Supplements that can delay commercial shipments by 6-12+ months.

EMA Q2 2026 Pilot Programme for Breakthrough Medical Devices and IVDs

The European Medicines Agency (EMA) is launching a pilot programme in Q2 2026 to provide expert panel advice for developers of breakthrough medical devices and in vitro diagnostics (IVDs). Manufacturers may request expert panel opinions on whether their products meet breakthrough criteria (novelty and positive clinical impact) and, if confirmed, obtain advice on clinical development strategies and appropriate pre-clinical or clinical data. The pilot builds on MDCG 2025-9 guidance and will inform the European Commission's proposed revisions to the MDR and IVDR.

NV BON Disciplinary Actions: Agreements, Fines, Probations, Suspensions

The Nevada State Board of Nursing issued disciplinary orders against multiple nurses including RNs, APRNs, LPNs, and CNAs for violations including unprofessional conduct, controlled substance violations, practicing without proper licensure, and failing to meet standards of practice. Actions include agreements, reprimands, fines ranging from $100 to several hundred dollars, probationary terms, required continuing education, and license denial.

NV Nursing Board 13 Disciplinary Actions Jul-Sep 2024

The Nevada State Board of Nursing issued 13 disciplinary actions against nurses and nursing assistants for the period July 31 through September 30, 2024. Actions included agreements for reprimand with continuing education, probation, license revocation, and voluntary surrender of licensure. Violations cited included unprofessional conduct, controlled substance/alcohol issues, patient privacy breaches, and failure to comply with Board orders.

Nevada State Board of Nursing Disciplinary Actions February-April 2025

The Nevada State Board of Nursing published disciplinary and licensure actions for the period February 3, 2025 through April 10, 2025. The document records multiple enforcement outcomes including license revocations, reprimands with continuing education requirements, renewal application denials, and voluntary surrenders. Violations cited include NRS 632.347 (unprofessional conduct, controlled substances, criminal convictions, action in another state) and NAC 632.890 (customary standards of practice, failure to collaborate with healthcare team, threats of violence).

Nevada State Board of Nursing Disciplinary Actions October 16 Through December 8 2025

Nevada State Board of Nursing published its quarterly disciplinary and licensure actions covering October 16 through December 8, 2025. The document summarizes multiple enforcement cases against registered nurses, advanced practice nurses, certified nursing assistants, and CNA applicants. Violations cited include NRS 632.347 (1)(g) unprofessional conduct, medication errors, unauthorized drug administration, scope of practice violations, diversion of supplies, and fraud in license procurement. Actions include agreements for reprimand, probation, practice restrictions, voluntary license surrender, application denial, and revocation orders.

Nevada Nursing Board Probations, Reprimands, License Denials, Surrenders

The Nevada State Board of Nursing published its disciplinary and licensure actions for the period December 8, 2025 through February 4, 2026. Actions taken include agreements for probation (terms of 18 months to 5 years), reprimands with required continuing education, CNA renewal application denials, and voluntary certificate surrenders. Violations cited include NRS 632.347 (unprofessional conduct), NAC 632.890 (various practice standards including inaccurate recording, falsifying records, practice beyond scope, customary standards of practice, and violation of state/federal nursing law), and NRS 632.415.

Public Comment Guidelines for Montana Board of Nursing Meetings

The Montana Department of Labor & Industry's Business Standards Division implemented public comment guidelines for professional and occupational licensing board meetings, including the Montana Board of Nursing, effective August 1, 2022. The guidelines establish procedures for public comment on non-agenda items and agenda items during board meetings, with written comments due seven days prior to scheduled meetings.

Public Comment Guidelines for Montana Nursing Board Meetings

The Montana Department of Labor & Industry Business Standards Division implemented public comment guidelines for professional and occupational licensing board meetings, effective August 1, 2022. The guidelines establish a consistent approach for public members to comment during board meetings, including procedures for submitting written comments at least seven days prior to scheduled meetings. The board may limit or close public comment periods and cannot act on items not on the current agenda.

Montana Board of Nursing Public Comment Guidelines for Meetings

The Montana Department of Labor & Industry's Business Standards Division implemented public comment guidelines for professional and occupational licensing board meetings effective August 1, 2022. The changes establish consistent procedures for public participation including non-agenda public comment periods and agenda item-specific comment periods, with written comments required seven days prior to scheduled meetings.

Public Comment Guidelines for Montana Professional Licensing Boards

The Montana Department of Labor & Industry's Business Standards Division implemented public comment guidelines for professional and occupational licensing board meetings effective August 1, 2022. The guidelines establish procedures for public comment during meetings, including requirements for written submissions to be made at least seven days before scheduled board meetings, with specifications for including name, organization representation, and agenda item references. These changes apply to all professional and occupational licensing boards under the Montana Department of Labor & Industry.

Public Comment Guidelines for Professional Licensing Board Meetings

The Montana Department of Labor & Industry Business Standards Division implemented public comment guidelines for professional and occupational licensing board meetings effective August 1, 2022. The guidelines standardize how public members may comment during board meetings, establish submission deadlines, and define procedural rules for comment periods. Nursing professionals, licensees, and members of the public seeking to participate in board meetings are affected by these procedures.

California Vocational Nursing Disciplinary Actions October 2025

The California Board of Vocational Nursing and Psychiatric Technicians published its October 2025 disciplinary actions report documenting accusations, citations, and final decisions against licensees. The report lists 16 accusations filed against vocational nurses, 2 statements of issues filed, 33 citations issued to licensees including VNs and PTs, and 16 final decisions and orders issued against vocational nurses and entities.

California Vocational Nursing Disciplinary Actions, November 2025

The California Board of Vocational Nursing and Psychiatric Technicians published November 2025 disciplinary records covering 29 accusation filings against vocational nurses, 29 citation issuances, and 6 decisions and orders. The records include respondent names, license numbers, and filing dates from November 4-25, 2025.

December 2025 CA VN Accusations, Citations, Decisions

CA BVNPT published December 2025 monthly enforcement summary listing 11 accusations filed against vocational nurses (License types VN), 25 citations issued to VN and PT licensees, and 7 decisions and orders filed including 1 entity. The document records administrative enforcement actions for the month of December 2025.

January 2026 VN Accusations, Citations, and Disciplinary Decisions

CA BVNPT published its monthly enforcement compilation for January 2026, documenting 17 accusations filed against VN and PT licensees, 38 administrative citations issued, 6 statements of issues filed, and 18 final disciplinary decisions and orders. All listed licensees hold either Vocational Nurse (VN) or Psychiatric Technician (PT) credentials issued by the California board.

February 2026 Accusations Citations and Decisions List

The California Board of Vocational Nursing and Psychiatric Technicians published its February 2026 enforcement summary documenting accusations filed, citations issued, and final decisions against licensees. The document records 12 accusations filed against vocational nurses, psychiatric technicians, and one registered nurse; 30 citations issued; and 6 decisions and orders finalizing prior enforcement actions.

Radiographic Head and Neck Positional Changes in Response to Low-Powered Prismatic Lenses

NIH's ClinicalTrials.gov has registered a new observational study (NCT07532642) investigating short-term modifications in head and neck positioning through use of low-powered prismatic lenses in patients with Postural Deficiency Syndrome. The matched-pair study will evaluate patients using low-dose biplanar radiography before treatment and 15 minutes after lens application.

Functional Outcomes and Control Using Synchron BCI - Australia (FOCUS-AUS)

NIH has registered a clinical trial on ClinicalTrials.gov for Synchron's brain-computer interface (BCI) device, known as the Stentrode. The FOCUS-AUS study will evaluate functional outcomes in patients with motor neuron disease and paralysis at Australian trial sites. The study has an anticipated completion date of April 16, 2026.

Berry Mango Leaves Extract for Acute Rhinosinusitis Phase I Trial, 10 Subjects

ClinicalTrials.gov registered a Phase I controlled clinical trial (NCT07534280) studying the safety and efficacy of Berry leaves and Mango leaves herbal tea mixture for management of acute rhinosinusitis in adults. Ten subjects aged 18-70 will be enrolled from Minia University ENT outpatient clinic and followed for one month with telephone assessments at Days 0, 3, 7, 10, and 28.

BREATHE III Brazilian Registry of Heart Failure

NIH registered BREATHE III, a prospective multicenter observational registry on ClinicalTrials.gov studying acute heart failure patients in Brazil. The 12-month follow-up study will assess patient characteristics, treatment patterns, guideline-directed medical therapy adherence, time to treatment optimization, and clinical outcomes including barriers to implementation and regional variations in care.

Skin Acceptability Test for GINPI in Female Volunteers

NIH ClinicalTrials.gov registered Study NCT07533461, a Phase 4 clinical trial evaluating skin acceptability of the cosmetic product GINPI in healthy female adult volunteers under gynecological control. The study assesses organoleptic characteristics, subjective efficacy, and monitors for unexpected adverse events over a twice-daily application regimen for 54 participants.

Nurses' Knowledge of Initiating Mechanical Ventilation in ICUs (NCT07534202)

NIH ClinicalTrials.gov registered an observational study (NCT07534202) assessing intensive care unit nurses' knowledge regarding initiation of mechanical ventilation and associated nursing procedures in hospitals in southern Iraq. The study is categorized as observational with no interventional component.

Phase 1 Solid Tumor Trial of BMS-986504 Plus Standard-of-Care Therapy

NIH's ClinicalTrials.gov registered a Phase 1 clinical trial (NCT07532902) evaluating BMS-986504 in combination with standard-of-care anticancer therapies for patients with metastatic/advanced unresectable MTAP-deleted solid tumor cancers. The study will enroll participants with diffuse pleural mesothelioma, gastroesophageal carcinoma, and urothelial carcinoma. This is a routine clinical trial registration providing public access to study design and eligibility criteria.

Sacral Fracture Fixation Trial Compares Open, Minimally Invasive Surgical Approaches

NIH's ClinicalTrials.gov has registered observational study NCT07534579 comparing open versus minimally invasive lumbopelvic fixation for unstable sacral fractures in adults. The retrospective study will review medical records and imaging of patients treated between January 2016 and December 2024 to evaluate physical function using the Majeed Pelvic Score, bone healing, surgical complications including wound infections and hardware failures, and clinical nerve function recovery.

Real World MAIA UK Outcomes - Observational Myeloma Trial, DRd Therapy

The NIH registered observational study NCT07532473 on ClinicalTrials.gov to assess real-world use and clinical outcomes of triplet therapy daratumumab, lenalidomide, and dexamethasone (DRd) in transplant-ineligible patients with untreated myeloma in the United Kingdom. The observational study will describe treatment patterns and associated clinical outcomes outside of clinical trial settings.

VAP-Measured Lipid Subfractions and In-Stent Restenosis After PCI (NCT07533656)

NIH registered multicenter observational study NCT07533656 investigating association between VAP-measured lipid/lipoprotein subfractions and coronary in-stent restenosis after PCI. Includes retrospective cross-sectional component (patients with prior PCI undergoing repeat angiography) and prospective follow-up component (patients undergoing index PCI). No additional blood draws required; serum samples from routine clinical collection used for VAP testing. Target enrollment: 140 participants. Conditions: In-Stent Restenosis, Coronary Artery Disease. No intervention.

Medicaid CCBHC Services State Plan Amendment Coverage Template PRA Notice

CMS published a Paperwork Reduction Act notice seeking public comments on the Medicaid Certified Community Behavioral Health Clinic (CCBHC) Services State Plan Amendment Coverage Template (CMS-10398 #45). The notice invites comments on burden estimates, necessity, utility, accuracy, and collection methods for this information collection request under OMB control number 0938-1148. Comments must be submitted by April 30, 2026.

Medicare Hospital IPPS FY 2027 Rates Proposed Rule Correction

CMS corrects a typographical error in the Medicare Hospital IPPS FY 2027 proposed rule published April 14, 2026. The correction changes the public comment deadline from incorrectly stated April 10, 2026 to the correct date of June 9, 2026.

CMS PRA Notice: Religious Nonmedical Health Care Institutions Conditions of Participation

CMS has published a 30-day notice under the Paperwork Reduction Act announcing an opportunity for public comment on an existing information collection for Religious Nonmedical Health Care Institutions (RNHCIs) Conditions of Participation. The notice covers compliance with health and safety requirements under Title 42 CFR Section 403, Subpart G. Comments on the burden estimate are due to the OMB desk officer by May 18, 2026.

Early Alert: Medical Action Industries Halyard Kit Recall - Angiographic Syringe Risk

FDA issued an early alert regarding Medical Action Industries convenience kits containing Medline Namic RA syringes subject to a Class I recall. The syringe rotating adaptor on affected devices may unwind during use, resulting in loose connections or full disconnection, with potential for biohazard exposure, blood loss, infection, air embolism, serious injury, or death. As of March 13, four serious injuries have been reported with no deaths. Affected parties must identify, segregate, and quarantine affected product and apply warning labels.

Phase 2 Clinical Trial Evaluating HSK55718 for Postoperative Pain in Abdominal Surgery

NIH registered a Phase 2 clinical trial (NCT07533786) evaluating the efficacy and safety of investigational drug HSK55718 for postoperative pain treatment. The multi-center, randomized, double-blind, placebo/active-controlled study plans to enroll 200 subjects undergoing abdominal surgery under general anesthesia, comparing three dose levels of HSK55718 against morphine and placebo.

AI Thai Food App and CGM Monitoring Pilot Study for Type 2 Diabetes

NIH's ClinicalTrials.gov has registered NCT07533604, an 8-week randomized controlled pilot study evaluating an AI-powered Thai food analysis application (SnapD) combined with continuous glucose monitoring (CGM) for glycemic control in 45 patients with Type 2 Diabetes and overweight/obesity. The study has three arms: SnapD alone, SnapD with CGM, or standard diabetes self-management education. Participants will be monitored over 8 weeks with HbA1c as the primary endpoint.

Potassium Channel Study in Chronic Cocaine Users

NIH registered a clinical trial (NCT07532460) on ClinicalTrials.gov investigating the role of potassium channels in working memory impairments among chronic cocaine users. The study will test 4-aminopyridine (4-AP) versus placebo as an intervention for cognitive impairments associated with cocaine use disorder. The trial is registered with an estimated start date of April 16, 2026.

Gas6 and Soluble MerTK Periodontal Biomarkers Study

NIH registered an observational clinical study (NCT07535177) investigating Gas6 and soluble MerTK biomarker levels in gingival crevicular fluid and serum samples across three groups: 30 patients with stage III grade B periodontitis, 30 with gingivitis, and 30 periodontally healthy individuals. The study will measure clinical periodontal parameters including probing depth, clinical attachment level, bleeding on probing, gingival index, and plaque index. Biomarker levels will be determined using enzyme-linked immunosorbent assay with non-parametric statistical analysis.

JZP3507 (ONC206) Phase 2 Trial for Recurrent Grade 2 or 3 Meningioma

NIH registered a Phase 2 clinical trial (NCT07533942) evaluating JZP3507 (ONC206) in patients with recurrent Grade 2 or 3 meningioma who have failed prior therapy. The single-arm study will administer oral JZP3507 and evaluate antitumor activity and safety. The trial is listed on ClinicalTrials.gov with an anticipated start date of April 16, 2026.

Short Fiber vs Injectable Resin Composite in Class I Restorations

NIH ClinicalTrials.gov registered a Phase 4 clinical trial (NCT07535086) comparing short fiber reinforced flowable bulk fill resin composite to conventional injectable flowable resin composite for restoring Class I carious molar cavities. The trial will evaluate clinical performance of these dental restoration materials. Estimated study completion date is April 16, 2026.

MINIMALLY INVASIVE SURGERY FOR GRADE III HEMORRHOIDS - Observational Study NCT07534761

NIH ClinicalTrials.gov registered a new observational study (NCT07534761) evaluating minimally invasive surgery (MIS) for Grade III hemorrhoids using a closed excisional hemorrhoidectomy technique. The IDEAL Phase 2a study aims to assess reproducibility and technical feasibility of MIS in anal surgery with approximately 50 participants.

Multicentre Retrospective Cohort Study of Palliative Care Pathways in Patients Who Died From Sarcoma

NIH ClinicalTrials.gov registered multicentre retrospective observational study NCT07532668 examining palliative care pathways in adult patients who died from sarcoma. The study aims to describe how sarcoma patients who died were followed by palliative care teams. No regulatory obligations or compliance requirements are imposed by this study registration.

Comparing Medial and Lateral Dissection Approaches to the Recurrent Laryngeal Nerve During a Thyroidectomy

NIH registered a new interventional clinical trial (NCT07532889) comparing medial versus lateral dissection approaches to the recurrent laryngeal nerve during thyroidectomy. The randomized study will evaluate length of hospital stay, surgical adverse events, and post-operative vocal cord function. Participants scheduled for thyroidectomy will be enrolled after informed consent.

Phase 1 KSD-101 Trial for EBV-Associated Hematological Malignancies

NIH ClinicalTrials.gov registered a Phase 1 study (NCT07532746) evaluating KSD-101 for relapsed or refractory EBV-associated hematological malignancies. The single-arm trial will assess safety, tolerability, preliminary efficacy, immune response, and quality of life in participants treated with KSD-101.

FCA Focus on Waste, Fraud, Data Analytics, Medicare Advantage

FCA Focus on Waste, Fraud, Data Analytics, Medicare Advantage

Sixth Circuit Holds ERISA Preempts Tennessee Pharmacy Anti-Steering Laws

In McKee Foods Corp. v. BFP Inc. (6th Cir., Apr. 7, 2026), the Sixth Circuit affirmed that ERISA preempts two Tennessee laws regulating pharmacy benefit managers (PBMs). The court held that the state's any-willing-provider provisions and incentive provisions, which aimed to prevent PBMs from steering patients to affiliated pharmacies, constituted impermissible interference with ERISA plan design and administration.

Pharmacy Compounding Advisory Committee Meeting and Bulk Drug Substances Public Comment Request

The FDA announces a Pharmacy Compounding Advisory Committee meeting scheduled for July 23-24, 2026, and establishes a public docket (FDA-2025-N-6895) to receive comments on bulk drug substances nominated for inclusion on the Section 503A Bulk Drug Substances List. The agency seeks input from stakeholders on whether these nominated substances should be approved for use in pharmacy compounding.

AREXVY RSV Vaccine Approved for Rare Pediatric Disease Priority Review Voucher

The FDA granted a Rare Pediatric Disease Priority Review Voucher to AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) under Docket No. FDA-2026-N-3446. The voucher, published at 91 FR 20460, was awarded upon approval of the vaccine product.AREAS XVY is manufactured by GSK and is indicated for active immunization against RSV disease in adults 60 years and older, and in infants through maternal immunization.