FSIS Notice: Public Health Information System Renewal
The Food Safety and Inspection Service (FSIS) has issued a notice announcing its intention to renew the Public Health Information System (PHIS) information collection. The agency is making no changes to the current system and is seeking public comments on the renewal.
ATSDR Seeks Nominations for Toxicological Profile Development Substances
The Agency for Toxic Substances and Disease Registry (ATSDR) is seeking nominations for substances to be evaluated for toxicological profile development. The public comment period for nominations closes on May 18, 2026.
Medical Device Recall: Incorrect Expiration Dates
Health Canada has issued a recall for several medical devices, including the Approach® CTO Micro Wire Guide and various catheter sets, due to incorrect expiration dates on the labelling. The manufacturer, Cook Incorporated, is providing information to healthcare professionals. This recall impacts multiple lot and model numbers.
Philips Recalls Allura Xper/Azurion Systems for X-ray Imaging Issues
Health Canada issued a recall for Philips Allura Xper and Azurion X-ray imaging systems due to performance issues with the wired foot switch. The recall affects multiple models and advises healthcare providers to contact the manufacturer for additional information.
Health Canada Recalls GEM PAKs for GEM Premier 5000 Due to Errors
Health Canada has issued a recall for GEM PAKs used with the GEM Premier 5000 due to an increased incidence of 'Process Control Solution Not Detected' errors. These errors can lead to GEM PAK ejection and require replacement, potentially delaying patient management.
Siemens RAPIDPoint 500 Blood Gas Systems Recall
Health Canada has issued a Type II recall for Siemens RAPIDPoint 500 Blood Gas Systems due to Measurement Cartridges potentially being exposed to temperatures outside specified storage conditions during transport. This may affect cartridge performance, and affected healthcare providers should contact the manufacturer.
Olympus Medical Cutting Forceps Recalled Due to Jaw Breakage Risk
Health Canada has issued a Type II recall for Olympus Medical PK/PKS/Everest Cutting Forceps due to a risk of jaw breakage during clinical use. The manufacturer identified inadequate supplier welding validation, and customers are requested to return affected products.
Health Canada Recalls Disinfectant Spray & Wipe Cleaner
Health Canada has issued a recall for specific lots of Coastwide CP15 Disinfectant Spray & Wipe Cleaner due to the active ingredient strength not meeting the labelled concentration. Retailers are instructed on the depth of the recall, and consumers are advised on actions to take.
ATSDR Toxicological Profile Public Comment Period
The Agency for Toxic Substances and Disease Registry (ATSDR) is providing a public comment period for its toxicological profiles. Interested parties can submit comments and attachments through the Regulations.gov portal. The deadline for submitting comments is May 18, 2026.
ATSDR Substance Nominations for Toxicological Profiles
The Agency for Toxic Substances and Disease Registry (ATSDR) is seeking public nominations for substances to be evaluated for upcoming toxicological profiles. This notice opens a comment period for interested parties to suggest substances and provide rationale, with comments due by May 18, 2026.
Nivolumab for Urothelial Cancer Appraisal Terminated
NICE has terminated the appraisal of nivolumab for urothelial cancer because the company failed to submit evidence. The guidance will be reviewed if the company decides to make a submission in the future.
Ruxolitinib cream for non-segmental vitiligo in people 12+
NICE has published updated technology appraisal guidance (TA1140) on ruxolitinib cream for treating non-segmental vitiligo in individuals aged 12 and over. This guidance replaces previous recommendations and includes information on commercial arrangements for the drug.
ANSM Safety Information for Hemostasis Reagent STA NeoPTimal 5
The French ANSM has issued a safety information notice regarding the Hemostasis Reagent STA NeoPTimal 5, manufactured by Diagnostica Stago. Affected users have been notified directly by the company, and the action is registered under ANSM number R2607353.
ANSM Drug & Device Safety Alert: Endoscopic Clip Device
The French ANSM has issued a safety information notice regarding a recall of specific lots of the Instinct Plus endoscopic clip device by Wilson-Cook Medical, Inc. This action follows a previous safety alert and is registered under ANSM reference R2606331.
ANSM Safety Recall: Autoimmunity IDS SS-A/Ro Reagent
The French ANSM has issued a safety recall (R2532493) for a specific lot of the Autoimmunity IDS SS-A/Ro reagent manufactured by Immunodiagnostic Systems (IDS). Laboratories using this reagent have been notified directly by the manufacturer.
Philips Respironics BiPAP A40 Pro Ventilator - Discontinuation and Safety Alert
Philips Respironics is discontinuing the BiPAP A40 Pro ventilator globally due to an internal oxygen sensor defect causing false alarms. The company offers patients options for continued care, including device replacement or partial reimbursement. Healthcare providers must inform affected patients of these options.
Curosurf 240 mg/3 ml Suspension Recall by Chiesi SAS
The French ANSM has announced a recall of a specific lot (Lot 1211845, Exp 07/2026) of Curosurf 240 mg/3 ml suspension for endotracheobronchial instillation. This action was initiated by the manufacturer, Chiesi SAS, as a precautionary measure due to a resolved deviation observed during environmental monitoring.
Philips Spectral CT Scanner Software Safety Alert
The French ANSM has issued a safety alert (R2607608) regarding Philips Spectral CT scanner systems with software version 5.1.X. Healthcare facilities using these devices have been notified of a security action initiated by Philips Medical Systems BV.
Leksell Vantage stereotactic system safety information
The French ANSM has issued a safety notice regarding the Leksell Vantage stereotactic system by Elekta Ltd. This action, registered under number R2607991, is based on a safety action implemented by the manufacturer. Affected healthcare facilities have been notified.
CMS Notice of Public Comment for Information Collection
The Centers for Medicare & Medicaid Services (CMS) is seeking public comment on its intention to collect information under the Paperwork Reduction Act. This notice provides a 60-day comment period for the public to review and provide feedback on proposed information collections, including extensions of existing ones.
Medicaid Home Health Face-to-Face Requirements public comment notice
Medicaid Home Health Face-to-Face Requirements public comment notice
Integra LifeSciences Convenience Kit Needle Recall
The FDA is alerting the public about a recall initiated by Integra LifeSciences for certain Convenience Kit Needles, specifically the Codman Microsensor Basic Kits and Cerelink ICP Sensor Basic Kits. Affected customers and distributors are instructed to immediately remove these devices from service or distribution.
FDA: Dialysis Tubing Sets Recalled Due to Dislodging, Updated Instructions
The FDA is alerting healthcare providers about a recall of Vantive dialysis tubing sets due to potential dislodging of the deaeration chamber. Updated instructions for use have been issued to mitigate risks, emphasizing monitoring the chamber during therapy. This is a correction and does not involve removing the devices from use or sale.
CMS Agency Information Collection Activities: 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 comments on the proposed collection, with a deadline of April 16, 2026.
CMS Agency Information Collection Activities Proposed Collection Comment Request
The Centers for Medicare & Medicaid Services (CMS) has published a notice proposing a new agency information collection activity and is seeking public comment. This notice outlines the proposed collection and provides a deadline for submitting comments.
DEA Seizes Over Half a Million Vape Cartridges and Drugs in San Diego
The DEA announced a massive seizure in San Diego, confiscating over half a million vape cartridges and other illicit drugs. This action highlights the ongoing threat posed by illegal substances to public health and safety, with multiple law enforcement agencies collaborating in the operation.
DEA Seattle Fentanyl Enforcement and Awareness Initiative
The DEA's Seattle Division is launching a "Fentanyl-Free America" initiative in the Pacific Northwest, focusing on increased enforcement, education, and awareness. This initiative aims to combat the fentanyl crisis through collaborative efforts.
CDC Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled “Land travel-related Public Health Activities” to the Office of Management and Budget (OMB) for review. This notice allows an additional 30 days for public and affected agency comments on the proposed data collection.
CDC Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) has submitted an information collection request titled “Aviation-related Public Health Activities” for review by the Office of Management and Budget. This notice provides an additional 30-day period for public comment on the proposed data collection.
CDC Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) has submitted the Maritime Illness Database and Reporting System (MIDRS) information collection request to the Office of Management and Budget (OMB) for review. This notice allows an additional 30 days for public comments on the proposed extension of this surveillance system.
CDC Seeks Nominations for Advisory Committee on Breast Cancer
The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on its Advisory Committee on Breast Cancer in Young Women. The committee comprises 15 experts in various fields related to breast cancer. Nominations must be received by April 20, 2026.
MHRA Field Safety Notices for Medical Devices
The MHRA has published a list of Field Safety Notices (FSNs) for medical devices issued between March 9-13, 2026. These notices are for informational purposes, and recipients are advised to act on any FSN received from a manufacturer.
MHRA NICE Integrated Scientific Advice Service Guidance
The MHRA and NICE have updated guidance on their Integrated Scientific Advice (ISA) service for medicine developers. The updates provide additional information on preparing for ISA meetings, including specific guidance on writing questions, creating briefing books, and understanding ISA reports and fees.
Ryan White HIV/AIDS Program Forms Submission to OMB for Review
The Health Resources and Services Administration (HRSA) has submitted revisions to the Ryan White HIV/AIDS Program: Allocations Report Forms to the Office of Management and Budget (OMB) for review and approval. A public comment period is open until April 16, 2026.
Court Blocks HHS Vaccine Policy Changes
A court has blocked changes to HHS vaccine policy, a decision praised by the American Medical Association (AMA). The AMA emphasized the importance of science-based immunization policies for public health and patient safety.
FDA Complaint Document Details
The FDA has posted details regarding a complaint document, with the information made available on March 16, 2026. The document is related to a complaint filed with the agency.
FDA Acknowledgment Letter to J.M.W. Entertainment Group
The FDA issued an acknowledgment letter to The J.M.W. Entertainment Group, LLC, regarding a submission. This notice confirms receipt of documentation by the FDA's Center for Devices and Radiological Health (CDRH).
FDA Complaint Document Posted
The FDA has posted a complaint document related to its regulatory activities. The document was made available on March 16, 2026, and was open for public comment. No specific details about the complaint's content or the nature of the comment period are provided.
FDA Variance Application from Audio Source, Inc
The FDA has posted a variance application from Audio Source, Inc. This document is available for review on the Regs.gov platform. The application pertains to medical device regulations.
FDA Variance Amendment from J.M.W. Entertainment Group
The FDA has posted a variance amendment from J.M.W. Entertainment Group, LLC. The document was made available on March 16, 2026, via the Regs.gov portal. No further details on the amendment's content are provided.
FDA Complaint Document
The FDA has posted a complaint document related to its activities, with the comment period closing on March 16, 2026. The document is available for public review and input.
FDA Complaint Posted for Public Comment
The FDA has posted a complaint for public comment, with the comment period closing on March 16, 2026. This action allows for public input on a specific complaint filed with the agency.
FDA Document on Contraceptive Status Among Females 15-49
The Food and Drug Administration (FDA) has issued a document concerning contraceptive status among females aged 15-49. This notice provides information on the topic without introducing new regulatory requirements.
FDA Study on Oral Contraception and HIV Risk in Africa
The FDA has published a notice regarding a study on the relationship between oral contraception and HIV risk in Africa. This notice is associated with docket number FDA-2026-P-2641-0031.
FDA Study on Contraceptives, Herpes, and HIV Risk
The FDA has posted a study concerning the relationship between contraceptives, herpes, and HIV risk. The study details are available through the agency's regulatory portal.
FDA Glucocorticoid Receptor Gene Expression Study
The FDA has posted a study concerning Glucocorticoid Receptor gene expression. This notice is for informational purposes and does not introduce new regulatory requirements.
FDA Acknowledgment Letter to Audio Source, Inc
The FDA has issued an acknowledgment letter to Audio Source, Inc. regarding a submission. This notice confirms receipt of the document by the agency.
FDA Background Material on Contraceptive Use and HIV-1 Transmission Risk
The FDA has posted background material concerning contraceptive use and the risk of HIV-1 transmission. This notice provides scientific information relevant to public health discussions and regulatory considerations.
Hormonal Contraceptive Eligibility for Women at High HIV Risk
The FDA has issued draft guidance regarding the eligibility of hormonal contraceptives for women at high risk of HIV. This guidance aims to clarify recommendations and ensure appropriate access to contraceptive methods while considering HIV prevention strategies.
FDA Progestins Classification and Pharmacology
The Food and Drug Administration (FDA) has published a document detailing the classification and pharmacology of progestins. This guidance provides information for manufacturers and pharmaceutical companies regarding these substances.
FDA Guidance on Progestins as Endocrine Disruptors
The FDA has issued new guidance concerning progestins and their potential role as endocrine disruptors. This document outlines the agency's current thinking and provides information relevant to manufacturers and public health authorities.
FDA Variance Application from J.M.W. Entertainment Group
The FDA has posted a variance application from The J.M.W. Entertainment Group, LLC. This document 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 notice.