Healthcare & Life Sciences

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.

MRESVIA RSV Vaccine Approval Under Material Threat Medical Countermeasure Priority Review Voucher

FDA approved MRESVIA (Respiratory Syncytial Virus Vaccine) using a Material Threat Medical Countermeasure Priority Review Voucher. The approval was announced via Federal Register Notice (Docket No. FDA-2026-N-3500, 91 FR 20467) on April 16, 2026. This action grants market authorization for the RSV vaccine, which was reviewed under an expedited pathway designed to encourage development of medical countermeasures addressing material public health threats.

Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; MRESVIA (Respiratory Syncytial Virus Vaccine)

FDA announces approval of MRESVIA (Respiratory Syncytial Virus Vaccine) and issuance of a Rare Pediatric Disease Priority Review Voucher under the voucher program established by the FDA Modernization Act of 2012. The approval was granted under Docket No. FDA-2026-N-3466 and published in 91 FR 20471 on April 16, 2026. This notice documents the completion of the regulatory review and voucher issuance for the vaccine product targeting RSV in pediatric populations.

MNEXSPIKE COVID-19 Vaccine Rare Pediatric Disease Priority Review Voucher Approval Notice

FDA issued a Notice announcing approval of MNEXSPIKE, an mRNA COVID-19 vaccine, under the Rare Pediatric Disease Priority Review Voucher program. The voucher program incentivizes development of treatments for rare pediatric diseases by providing priority review vouchers that can be used for future FDA review requests. Docket No. FDA-2026-N-3447.

Jessica de Mounteney Appointed First Parliamentary Counsel

Jessica de Mounteney has been appointed as the new First Parliamentary Counsel and Permanent Secretary of the Government in Parliament Group at the Cabinet Office, effective end of April 2024. She succeeds Dame Elizabeth Gardiner, who is departing after over 32 years of dedicated service. The appointment was made by the Prime Minister upon the recommendation of the Leader of the House of Lords. This is a routine administrative appointment to a senior civil service position within the UK's legislative drafting function.

Common Legislative Solutions: Guide to Tackling Recurring Policy Issues in Legislation

The Office of the Parliamentary Counsel has published updated guidance titled 'Common Legislative Solutions' to help government officials address recurring policy issues through commonly adopted legislative approaches. The guidance, produced with input from UK legislative drafting offices, identifies common policy problems and analyses possible legislative solutions. The document was last updated on 23 December 2025 with a new version of the guide.

Legislative Drafting: A Fictional Example

The Office of the Parliamentary Counsel published a fictional example illustrating its legislative drafting practice. The document shows how drafters translate government policy into legal language and subject policy to rigorous analysis to ensure provisions achieve their aims coherently. The example includes drafting instructions, an initial clause attempt, and a covering note demonstrating the iterative process between drafter and department.

Fecal Microbiome Signature of Multi-Strain Probiotics Supplementation in Pediatric IBD

The NIH has registered a clinical trial (NCT07533890) to study fecal microbiome and metabolic profiles in children and adolescents with inflammatory bowel disease upon multi-strain probiotic supplementation. The study will enroll participants and begin interventions on April 16, 2026.

Leaf Expander vs Hyrax for Molar Distalization

NIH ClinicalTrials.gov registered a randomized controlled trial comparing skeletally anchored modified Leaf Expander versus conventional Hyrax Expander for maxillary molar distalization in 30 patients aged 15-18 years. The three-year study will evaluate skeletal, dental, and arch dimensional changes using lateral cephalometric radiographs and digital dental models.

Hungarian ICU Transfusion Practices Survey

NIH ClinicalTrials.gov registered observational study NCT07532772, a Hungarian nationwide survey assessing transfusion practices in intensive care units. The study will evaluate how physiological parameters recommended as transfusion triggers are used in daily clinical practice across Hungarian hospitals. No regulatory obligations or compliance requirements are imposed by this registration.

MPXV Viral Clearance, Transmission Dynamics, and Vaccine Effectiveness Study in Guinea

NIH's ClinicalTrials.gov registered an observational study (NCT07534267) in Guinea, West Africa examining Monkeypox virus (MPXV) elimination kinetics from infected individuals, transmission dynamics between cases and contacts, and effectiveness of the MVA-BN vaccine against MPXV infection and Mpox disease. The study has three components: MOVIE-West Africa, TRACE-West Africa, and VE-West Africa.

Ga-68 PSMA PET/CT vs mpMRI in Cognitive Prostate Biopsy (NCT07533344)

The NIH ClinicalTrials.gov registry has registered observational study NCT07533344, an NCI-affiliated trial conducted by Stanford University comparing Ga-68 PSMA PET/CT imaging with multiparametric MRI (mpMRI) in cognitive prostate biopsy for prostate cancer diagnosis. The single-arm study will enroll approximately 100 participants and is estimated to begin enrollment on April 16, 2026.

DEA Addresses Drug Threats, Pharmacy Crime at Diversion Summit

DEA Assistant Administrator Cheri Oz addressed emerging drug threats, pharmacy crime, and prescription drug misuse at the National Association of Drug Diversion Investigators Rx Diversion Summit in Covington, KY. The remarks targeted over 300 pharmacists, investigators, and hospital leaders on controlled substance enforcement priorities.

Single-dose 7.2mg Semaglutide (Wegovy) Pen Approved for Adult Obesity

The MHRA approved a new single-dose 7.2mg semaglutide (Wegovy) pen for adult patients with obesity (BMI ≥30kg/m²). The approval consolidates the maximum weekly dose into one injection rather than three separate 2.4mg doses. Starting dose is 0.25mg weekly, gradually increasing every four weeks as prescribed. The agency will continue monitoring safety and effectiveness.

Synthetic CAR-T Cells for Treating IL13Ra2 Positive Human and Canine Tumors

The European Patent Office published patent application EP4021464A1 (A1 kind, April 8, 2026) for synthetic CAR-T cells targeting IL13Ra2 positive tumors in humans and canines. Applicant is The Trustees of The University of Pennsylvania. Inventors include O'ROURKE, Donald M., YIN, Yibo, JOHNSON, Laura, BINDER, Zev, and THOKALA, Radhika. The patent covers compositions and methods for treating IL13Ra2-positive tumors using synthetic chimeric antigen receptor T-cells.

Gene Therapy for Alzheimer's Disease - Brigham and Women's Hospital EP3976637

The European Patent Office published patent application EP3976637A1, filed by The Brigham and Women's Hospital, Inc. and The General Hospital Corporation, covering a gene therapy approach for treating Alzheimer's disease. The invention, developed by inventors Shen Jie and Kelleher III Raymond J., is classified under C12N 15/86 and related protein classification C07K 14/47. The patent is designated across all EU member states including AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LI, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, and TR.

Dexcom EP4318489A2 Patent, Continuous Glucose Monitoring App Compatibility Check

The European Patent Office published patent application EP4318489A2 for Dexcom, Inc. covering a system and method for verifying compatibility of continuous glucose monitoring (CGM) applications. The patent application includes claims related to wireless communication protocols (H04W 4/20), healthcare data management systems (G16H 40/40), and software update mechanisms (G06F 8/65) for medical device applications. The patent is designated across 31 EPO member states including Germany, France, Italy, Spain, and the United Kingdom.

Determining Structured Medical Findings in a Medical Report and Adjusting a Medical Report

The EPO published patent application EP4553842A1 by Koninklijke Philips N.V. titled 'Determining Structured Medical Findings in a Medical Report and Adjusting a Medical Report.' The invention covers methods for extracting structured findings from medical reports and adjusting medical report content. The patent is classified under G16H (Health Informatics) and designates 36 European countries including Germany, France, and the United Kingdom.

Governor Stein Recognizes Black Maternal Health Week, Highlights Maternal Health Disparities

Governor Josh Stein joined Senator Natalie Murdock and the North Carolina Legislative Black Caucus to recognize Black Maternal Health Week and raise awareness of racial disparities in maternal health outcomes. According to NCDHHS, Black women in North Carolina are nearly twice as likely as white women to die from pregnancy complications, with 57% of pregnancy-related deaths occurring during pregnancy or within six weeks postpartum and nearly 80% deemed preventable. The Governor highlighted budget investments including $319 million for Medicaid and $213 million through the Rural Health Transformation Program to improve maternal care access.

Government Response to ACMD 3 Medicines Reports on Drug Scheduling

The UK government agrees with ACMD recommendations to control three growth hormones (somapacitan, lonapegsomatropin, somatrogon) under Class C of the Misuse of Drugs Act 1971 and Schedule 4 (Part 2) of the Misuse of Drugs Regulations 2001. Ganaxolone will not be scheduled at this time. Zuranolone will be controlled under Class C and Schedule 4 (Part I) for treatment of post-natal depression.

Letter on ACMD Work Programme 2026

The Advisory Council on the Misuse of Drugs (ACMD) published its work programme for 2026, outlining planned advisory activities and ongoing ministerial commissions. The letter from the ACMD Chair to the Minister for Policing and Crime details both requested advice and self-initiated work the council will undertake during the year.

Register of ACMD Members' Interests and Occupations

The Advisory Council on the Misuse of Drugs (ACMD) maintains a register of interests for its council members, listing their occupations, employing organisations, and declared interests. The document was updated on 23 March 2026 to add a new trustee position for Roger Knaggs and on 17 March 2026 to update Professor Keith Humphreys' interests. Two new members, Professor Steve Allsop and Professor Keith Humphreys, were added with their declarations of interests on 2 February 2026. The register is an administrative transparency document for UK government advisory council members.

Professor Allsop, Professor Humphreys Join ACMD

The Advisory Council on the Misuse of Drugs (ACMD) has appointed Professor Steve Allsop and Professor Keith Humphreys as new members effective 1 February 2026. Professor Allsop is Emeritus Professor at the National Drug Research Institute, Curtin University, Australia. Professor Humphreys is the Esther Ting Memorial Professor in the Department of Psychiatry and Behavioural Sciences at Stanford University. These appointments follow 14 other experts joining the ACMD in 2025.

Ethylbromazolam Review Recommends Class C Control Under Misuse of Drugs Act 1971

The Advisory Council on the Misuse of Drugs published a review on 14 April 2026 recommending that the novel benzodiazepine ethylbromazolam be made a Class C drug under the Misuse of Drugs Act 1971 and added to Schedule 1 of the Misuse of Drugs Regulations 2001. The recommendation is based on evidence of misuse and harms associated with the substance.

Appealing NCIA Decision Process Steps

ACCIA published guidance on 31 March 2026 outlining the process for appealing decisions on National Clinical Impact Award (NCIA) applications in England and Wales. The guidance specifies procedural grounds for appeal including discrimination, bias, conflicts of interest, or failure to follow standard evaluation processes. Medical and dental professionals must request an appeal within 28 days of receiving their award outcome notification.

ACCIA Sub-Committees and Their Role in Scoring NCIA Applications

The Advisory Committee on Clinical Impact Awards (ACCIA) published guidance on the role of 13 regional sub-committees in England in assessing National Clinical Impact Award (NCIA) applications. Sub-committee members (50% medical/dental professionals, 25% non-medical/lay members, 25% employers) score applications against standardised guidance, with top-ranked applicants referred to N3 national re-scoring. Separate sub-committees handle DHSC/arm's length body applications, highest-scoring regional applicants, and tied applications at cut-off points.

NHS Consultants Guide, National Clinical Impact Awards 2026

The Advisory Committee on Clinical Impact Awards published guidance on 31 March 2026 for NHS consultant doctors, dentists, and academic GPs in England and Wales on applying for national Clinical Impact Awards in 2026. The guidance covers eligibility requirements, the application process, scoring criteria, and transition arrangements for holders of National Clinical Excellence Awards moving to the new scheme.

Clinical Impact Awards 2026: Employers' Guide

The Advisory Committee on Clinical Impact Awards published guidance for the 2026 national Clinical Impact Awards competition in England and Wales. The guide sets out employer responsibilities in supporting NHS consultant doctors, dentists, and academic GPs through the application process. Employers are advised to read the guide before signing off applications and use it as a reference resource.

VICH GL8(R1) Draft Guidance: Stability Testing for Medicated Premixes (Revision 1)

The FDA announced availability of draft guidance for industry GFI #91 (VICH GL8(R1)) on stability testing for medicated premixes for veterinary use. Developed through the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), this revision updates recommendations for stability testing of medicated premixes intended for oral administration following incorporation into animal feed. The draft is open for public comment until June 15, 2026.

Importation of Prescription Drugs Comment Request

The FDA has published a notice in the Federal Register announcing an opportunity for public comment on a proposed information collection related to the importation of prescription drugs. Under the Paperwork Reduction Act, the Agency seeks public input on existing information collection requirements. The comment period closes on June 15, 2026.

SAMHSA Proposes PAIMI Program Performance Report Data Collection Under PRA

SAMHSA published a 60-Day Notice in the Federal Register seeking public comment on information collection activities for the Protection and Advocacy for Individuals with Mental Illness (PAIMI) Revised Annual Program Performance Report (PPR). The notice requests comments on whether the proposed data collection is necessary, accurate, and minimally burdensome. The OMB clearance for the current 2024-2025 PPR expires July 31, 2026, and SAMHSA is seeking approval for updates to the reporting requirements.

Medicaid and CHIP Generic Information Collection Activities: Proposed Collection; Comment Request

CMS published a Federal Register notice seeking public comment on generic information collection activities under OMB control number 0938-1148 (CMS-10398). The collections relate to Medicaid and CHIP State plan amendments, waivers, demonstrations, and reporting under a generic clearance process approved by OMB. Comments must be received by April 30, 2026.

Medicare IPPS FY 2027 Correction: Comment Deadline Changed from April 10 to June 9, 2026

CMS issued a correction to a previously published proposed rule for Medicare IPPS FY 2027. The correction fixes a typographical error in the DATES section, changing the public comment deadline from April 10, 2026 to June 9, 2026. The correction applies to the proposed rule published April 14, 2026 (FR Doc. 2026-07203, 91 FR 19312).

Agency Information Collection Activities: Submission for OMB Review; Comment Request

The Centers for Medicare and Medicaid Services (CMS) has published a notice under the Paperwork Reduction Act of 1995 announcing an opportunity for public comment on proposed information collections identified as CMS-10712 and CMS-10266. The notice invites interested persons to submit comments on the burden estimates and aspects of these proposed collections to the Office of Management and Budget (OMB). Comments must be received by May 18, 2026.

Clinical Impact Awards Transition Arrangements for Award Holders

The Advisory Committee on Clinical Excellence Awards and Advisory Committee on Clinical Impact Awards announce transition arrangements for national Clinical Excellence Award holders moving to the new Clinical Impact Awards scheme. Transition provisions include pay protection and pensionability of full award value for the first award period. New awards will commence on 1 April following announcement of results.