CMS Notice on Plan Benefit Package and Formulary CY 2027 Information Collection
CMS is providing an opportunity for public comment on its intention to collect information regarding the Plan Benefit Package (PBP) and Formulary for CY 2027. This notice is part of the Paperwork Reduction Act process, requiring agencies to seek public input on information collections.
Famodine Tablet 20mg Recalled Due to Assay Test Result
The Health Sciences Authority (HSA) Singapore has initiated a retail-level recall of Famodine Tablet 20mg (famotidine) due to out-of-specification assay test results. The affected batch (232218) must be stopped from supply and returned to the company.
Texas Board of Pharmacy Newsletter - March 2026
The Texas Board of Pharmacy has issued its March 2026 newsletter, providing updates on continuing education requirements, the Prescription Drug Monitoring Program (PMP), scam alerts, and licensing information. The newsletter also includes details regarding an upcoming board meeting.
WHO HRP Receives $7.2M Funding Commitment for Sexual and Reproductive Rights
The Children's Investment Fund Foundation (CIFF) has committed US$ 7.2 million to the WHO's HRP programme for research in human reproduction. This funding aims to advance sexual and reproductive health and rights globally, particularly in light of cuts to development assistance.
WHO Guidance on Institutionalizing Health Emergency Simulation Exercises
The WHO has released new global guidance to help countries establish National Health Simulation Exercise Programmes (NHSEP). This guidance encourages a shift from ad-hoc drills to structured, government-led programs for testing and strengthening health emergency preparedness.
B. Braun Medical Inc. Urgent Correction for Hemodialysis Bloodlines
B. Braun Medical Inc. issued an urgent medical device correction for specific hemodialysis bloodlines due to the potential formation of air bubbles. The FDA is issuing an Early Alert to notify the public and advise healthcare providers to use alternate equipment or follow specific mitigation steps if the affected devices must be used.
ANSM Suspends Institut Georges Lopez, Recalls Celsior Lots
The French ANSM has suspended the manufacturing authorization for Institut Georges Lopez (IGL) and recalled all lots of its organ preservation solution, Celsior, produced since March 2024 due to serious manufacturing non-conformities posing a high risk of microbiological contamination. An update on March 25, 2026, indicates IGL has come into compliance, and its manufacturing authorization has been reinstated.
Rivaroxaban Viatris Lot Recalled Due to Quetiapine Contamination
The French ANSM has ordered a recall of a specific lot (8212020) of Rivaroxaban Viatris 20mg tablets due to cross-contamination with quetiapine. Patients holding this lot are advised to return it to pharmacies for exchange.
HHS FISMA Compliance Report: Not Effective, 10 Recommendations Made
The HHS Office of Inspector General (OIG) has released a report rating HHS's compliance with the Federal Information Security Modernization Act (FISMA) for Fiscal Year 2025 as 'Not Effective' for the sixth consecutive year. The report details ten recommendations to improve HHS's information security program.
OSHA Logging Operations Standard Information Collection Request Consultation
OSHA is requesting public comments on the proposed extension of OMB approval for information collection requirements related to its Logging Operations Standard. The comment period closes on May 26, 2026.
Rivaroxaban Viatris 20 mg tablet safety information
The French National Agency for the Safety of Medicines and Health Products (ANSM) has issued safety information regarding Rivaroxaban Viatris 20 mg tablets. This alert highlights specific safety considerations and potential risks associated with the use of this medication.
ANSM Safety Information for Pre-analytical Tube
The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety recall (R2607993) for the Vacuette CTAD 3.5ml pre-analytical tube manufactured by Greiner Bio-One. Affected medical laboratories have been notified directly by the manufacturer.
ANSM Drug & Device Safety Alert: Recall of Anti-Ig M-PER Reagent
The French ANSM has announced a recall of a specific lot of the Anti-Ig M-PER reagent used in Hydragel kits by Sebia. This safety action, registered under number R2607839, is intended for medical biology analysis laboratories.
ANSM Safety Alert: Radius VSM ECG Electrodes and Blood Pressure Cuffs
The French ANSM has issued a safety alert regarding a lot recall of Radius VSM ECG electrodes and blood pressure cuffs by Masimo Corporation. This action is registered under recall number R2607611 and is directed at pharmacies and healthcare facilities.
Navajo Heating Pad Recalled for Overheating and Burn Risk
The FDA has identified a Class I recall for Navajo Manufacturing Company's Handy Solutions Neck & Shoulders Heating Pad (Model 25607) due to an overheating and burn risk. The company is removing the affected devices from the market, and consumers are advised to immediately discontinue use, cut the power cord, and dispose of the product.
Amneal Pharmaceuticals Recalls Magnesium Sulfate Due to Product Mix-Up
Amneal Pharmaceuticals LLC is voluntarily recalling one lot of Magnesium Sulfate in Water for Injection, USP, 4g/100mL, due to a product mix-up where a pouch contained an IV bag of Tranexamic Acid. The recall is to the hospital level nationwide. The company has received no adverse event reports related to this recall.
Erbe USA Recalls Flexible Cryoprobes Due to Injury or Death Risk
Erbe USA is recalling flexible cryoprobes due to a risk of serious injury or death from device rupture during activation. The FDA has identified this as the most serious type of recall. Customers are instructed to discontinue use, remove, and quarantine affected devices.
DEA Seattle Seizes 880lbs THC Vape Oil and Processing Equipment
The DEA Seattle Division announced the seizure of 880lbs of THC vape oil, 760lbs of processed marijuana, and a machine capable of filling 4,000 vape cartridges per hour. The owner was found to be shipping these products illegally, indicating a significant bust in illicit cannabis operations.
DEA Diversion Control Division Industry Day on IT Modernization
The DEA announced an upcoming Industry Day on March 26, 2026, focused on IT modernization efforts supporting its Diversion Control mission. The event aims to discuss regulatory, legal, compliance, and enforcement missions.
DEA Houston Seizes Drugs and Firearms from Apartment
The DEA Houston Division, with assistance from local law enforcement, seized approximately 40 lbs. of methamphetamine, 20 grams of fentanyl, cocaine, over 100 lbs. of marijuana, and 17 firearms from a Southeast Houston apartment. This action highlights ongoing efforts to combat drug trafficking and illegal firearm possession.
OSHA Logging Operations Standard OMB Approval Extension Announced
The Occupational Safety and Health Administration (OSHA) announced an extension of the Office of Management and Budget's (OMB) approval for information collection requirements related to the Logging Operations Standard. This notice pertains to the administrative approval of data collection and reporting under the existing standard.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) has submitted an agency information collection activity for review by the Office of Management and Budget (OMB). This notice requests public comment on the proposed collection.
ECHA Consultation on Draft SEAC PFAS Opinion
The European Chemicals Agency (ECHA) will launch a 60-day public consultation on a draft opinion from its Committee for Socio-Economic Analysis (SEAC) regarding a universal restriction proposal for all per- and polyfluoroalkyl substances (PFAS). The consultation period will run from March 26 to May 25, 2026.
FDA Warning Letter to 4U Health for Adulterated Biologics
The FDA issued a warning letter to 4U Health for distributing an unapproved HIV serological diagnostic dried blood spot self-collection kit. The kit is considered adulterated and misbranded because it lacks the required premarket approval or investigational device exemption.
FDA Warning Letter to Yangzhou H&R Plastic Daily Chemical Co., Ltd.
The FDA issued a warning letter to Yangzhou H&R Plastic Daily Chemical Co., Ltd. following an inspection that revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations. The company failed to adequately test drug products for identity and strength before release and did not properly test incoming components.
FDA Warning Letter to Matesbrand.com for Nicotine Pouches
The FDA issued a warning letter to matesbrand.com for illegally marketing new tobacco products, specifically nicotine pouches, without required premarket authorization. The agency determined that the listed nicotine pouch products are adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act.
FDA Warning Letter to Longhorn Vaccines and Diagnostics LLC
The FDA issued a warning letter to Longhorn Vaccines and Diagnostics LLC regarding violations of the Quality System Regulation for their PrimeStore® MTM device. The inspection revealed that the devices are adulterated due to inadequate complaint file maintenance and failure to establish proper complaint handling procedures, including evaluating complaints for medical device reporting.
FDA Warning Letter to ImmunityBio Inc. Regarding ANKTIVA®
The FDA issued a warning letter to ImmunityBio Inc. concerning promotional communications for its drug ANKTIVA®. The FDA determined that a direct-to-consumer broadcast advertisement and a podcast were false or misleading, misbranding the drug and violating the Federal Food, Drug, and Cosmetic Act. The agency expressed concern that these communications create a misleading impression that ANKTIVA can cure or prevent all cancer.
Center for Scientific Review Meeting Notice Amended
The National Institutes of Health (NIH) has issued an amended notice regarding a meeting of the Center for Scientific Review. This notice updates previously published information about the meeting.
National Institute of Neurological Disorders and Stroke Closed Meetings Notice
The National Institutes of Health (NIH) has published a notice regarding closed meetings for the National Institute of Neurological Disorders and Stroke. This notice informs the public about upcoming meetings that will be closed to the public.
Center for Scientific Review; Notice of Closed Meetings
The National Institutes of Health (NIH) Center for Scientific Review has published a notice announcing upcoming closed meetings. These meetings are scheduled to take place on April 20-21, 2026.
Center for Scientific Review Closed Meetings Notice
The National Institutes of Health (NIH) published a notice regarding closed meetings for the Center for Scientific Review. These meetings are scheduled for April 20, 2026, and are part of the standard review process for grant applications.
National Cancer Institute Meeting Announcement
The National Institutes of Health, through the National Cancer Institute, has announced an upcoming meeting. The notice provides details regarding the meeting, which is scheduled for April 8, 2026. This announcement serves as an informational update for interested parties.
FDA Reclassifies Melanoma Detection and Impedance Devices
The FDA has reclassified certain optical diagnostic devices for melanoma detection and electrical impedance spectrometers. These devices will now be renamed Software-Aided Adjunctive Diagnostic Devices for Use on Skin Lesions by Physicians Trained in the Diagnosis and Management of Skin Cancer. This reclassification aims to better categorize these diagnostic tools.
FDA Complaint Document Details
The FDA has posted a complaint document related to its activities, identified by docket number FDA-2026-H-2617-0001. The document is available for review on the Regulations.gov portal.
FDA Complaint Document
The FDA has posted a complaint document authored by CTP. The document was made available on March 24th and is now closed for public comments. No specific details about the complaint's content or the regulatory impact are provided.
FDA Complaint Document
The FDA has posted a complaint document related to its Center for Tobacco Products (CTP). The document was made available on March 24, 2026, and is open for public comment.
FDA Complaint Document
The Food and Drug Administration (FDA) has posted a complaint document related to its activities. The document is available for review on the Regs.gov platform. No specific action is required from regulated entities at this time.
FDA Complaint Document
The FDA has posted a complaint document related to its regulatory activities. The document is available for download and further information can be accessed via the provided link. This notice serves to inform the public about the availability of this complaint.
FDA Complaint Document
The Food and Drug Administration (FDA) has posted a complaint document related to its activities. This document is now closed for public comments. The FDA has provided a link to download the complaint document.
FDA Delays Effective Date for Spirulina Extract Color Additive
The FDA is delaying the effective date of its final order regarding the expanded use of spirulina extract as a color additive in human foods. This delay is due to timely objections and a request for a hearing filed by Obelisk Tech Systems Inc. The agency will publish a future document to announce a new effective date or other administrative action.
FDA Variance Approval Letter to Anthony Ritzko
The FDA's Center for Devices and Radiological Health (CDRH) has issued a variance approval letter to Anthony Ritzko. The letter, dated March 24, 2025, is available in both redacted and unredacted forms.
FDA Complaint Document Filed
The Food and Drug Administration (FDA) has filed a complaint document related to tobacco regulations. The document is available for review on the Regs.gov platform.
FDA Complaint Document
The FDA has posted a complaint document related to its activities, identified by docket number FDA-2026-H-2424-0001. The document is available for review on the Regs.gov platform.
FDA Variance Application from Aquatic Multimedia LLC
The FDA has posted a variance application from Aquatic Multimedia LLC. This document, submitted by CDRH, is available for review on the Regs.gov platform. No further details on the nature of the variance or its implications are provided in the available information.
FDA Complaint Filed
The Food and Drug Administration (FDA) has filed a complaint on March 24, 2026. The complaint is related to tobacco product regulation and was authored by CTP. Further details are available via the provided URL.
FDA Complaint Filed and Closed for Comments
The Food and Drug Administration (FDA) has filed a complaint and closed the comment period for this matter. The specific details of the complaint are not available for viewing or download within the provided document.
FDA Complaint Document Closed for Comments
The FDA has closed a comment period for a complaint document related to its Center for Tobacco Products (CTP). The document, identified by docket number FDA-2026-H-2885, is no longer accepting public feedback.
FDA Completeness Assessment Correspondence
The Food and Drug Administration (FDA) has issued a completeness assessment correspondence to Hyman, Phelps & McNamara, P.C. This document is part of the ongoing regulatory process for a submission, but no specific details about the assessment or the submission are provided in the available information.
FDA Delays Effective Date for Spirulina Extract Color Additive
The FDA is delaying the effective date of its final order regarding the expanded use of spirulina extract as a color additive in human foods. This delay is in response to timely objections and a request for a hearing filed by Obelisk Tech Systems Inc. The agency will announce a new effective date or other administrative action later.
National Vaccine Injury Compensation Program Petitions Received
The Health Resources and Services Administration (HRSA) has published a notice listing petitions received for the National Vaccine Injury Compensation Program. This notice serves as an informational update regarding the program's filings.
FSIS Advance Notice of Proposed Rulemaking on Establishment Size Definitions
The Food Safety and Inspection Service (FSIS) has issued an advance notice of proposed rulemaking to solicit public input on revising its definitions of establishment sizes for meat, poultry, and egg products plants. FSIS is considering updating its current HACCP size categories and volume-based thresholds used for regulatory analysis and agency sampling frequencies.
HHS Final Rule Adopts Health Care Claims Attachment Standards
The Department of Health and Human Services (HHS) has issued a final rule establishing standards for health care claims attachments transactions and electronic signatures. This rule, effective May 26, 2026, aims to reduce administrative burden and improve data exchange efficiency between health plans and providers.
USPTO Patent Grant: Bispecific Antibodies Targeting CD47 and PD-L1
The USPTO has granted patent US12583922B2 for bispecific antibodies targeting CD47 and PD-L1. The patent, assigned to Novimmune SA, covers methods of making and using these antibodies for treating cancers associated with malignant cells expressing CD47 and/or PD-L1.
USPTO Patent Granted for MUC1 Antibodies for Cancer Treatment
The USPTO has granted patent US12583927B2 to Minerva Biotechnologies Corporation for MUC1 antibodies designed for cancer treatment. The patent covers antibodies that specifically bind to the PSMGFR peptide or its fragments, offering potential new diagnostic and therapeutic applications.
USPTO Patent Grant: Antibody and CAR Binding to CD70 for Disease Treatment
The USPTO has granted patent US12583931B2 to Nanjing IASO Biotechnology Co., Ltd. for an antibody and chimeric antigen receptor (CAR) that specifically binds to CD70, intended for treating diseases related to CD70 expression. The patent covers the composition of the CAR and its application in disease treatment.
Patent Grant: IGFR-like Receptor Antagonists for Diabetes Treatment
The USPTO has granted a patent (US12583928B2) for novel Insulin-like Growth Factor 1 Receptor (IGFR)-like receptor antagonists and agonists. These compounds are intended for the treatment of diabetes.
iVascular Navitian Recall
Health Canada has issued a Type II recall for the iVascular Navitian medical device due to a potential risk of material fragment loss from outer layer deterioration. The recall affects specific lot and serial numbers and is being managed by the manufacturer, Life Vascular Devices Biotech S.L.
Olympus HF Cable Recall
Health Canada has issued a Type II recall for the Olympus HF Cable (Model WA00014A) due to performance issues leading to insulation wear, corrosion, and failure. The recall follows 109 complaints, including 17 reports of minor burns, though no serious injuries were reported.