Healthcare & Life Sciences

PRAC Recommendations on Safety Signals

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted recommendations on safety signals discussed in November 2025. Marketing Authorisation Holders (MAHs) are required to provide supplementary information or update product information based on these recommendations, with specific deadlines for certain signals.

PRAC Recommendations on Safety Signals

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted recommendations on safety signals discussed between September 29 and October 2, 2025. These recommendations are directly actionable by marketing authorisation holders (MAHs) for both Centrally Authorised Products (CAPs) and Nationally Authorised Products (NAPs).

ANSM Safety Information: Mobile Hoist and Bath Elevator

The French National Agency for Medicines and Health Products Safety (ANSM) has issued safety information regarding a mobile hoist and bath elevator from Mangar International. This notice, registered under number R2607055, alerts home healthcare providers and retailers to a safety action implemented by the manufacturer.

Safety alert for DermaGenius 3.0 reagent

The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety alert regarding the DermaGenius 3.0 Complete Multiplex real-time PCR reagent. This alert, registered under number R2607183, informs medical biology analysis laboratories of a security action implemented by PathoNostics.

Spinal Plug Safety Alert for Pharmacies

The French ANSM has been informed of a lot recall action for spinal plugs (Airplug T10-T12) by Groupe Lépine, registered under action number R2607057. Pharmacies are directed to consult the provided letter from the manufacturer for details.

ANSM Safety Alert for Manosplint Cushionfoam Medical Device

The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety alert regarding the Manosplint Cushionfoam medical device, identified by safety action number R2606620. This alert concerns a safety action initiated by the manufacturer, Kinetec SAS.

ArjoHuntleigh Tenor Mobile Hoist Safety Alert

The French National Agency for the Safety of Medicines and Health Products (ANSM) has announced a product recall for the ArjoHuntleigh Tenor mobile hoist. This action, registered under number R2606757, is being implemented by the manufacturer ArjoHuntleigh AB.

ICH Consultations on Patient Preference, Extractables, and Adaptive Trials

Health Canada announced three International Council for Harmonisation (ICH) draft guidelines are open for public consultation. The consultations cover patient preference studies, extractables and leachables, and adaptive clinical trials, with comment deadlines ranging from November 2025 to April 2026.

Health Canada Implements ICH Q12 and Q14 Guidance

Health Canada has announced the implementation of International Council for Harmonisation (ICH) Q12 and Q14 guidance. The initial scope focuses on Post Approval Change Management Protocols (PACMPs) for Biologic and Radiopharmaceutical Drugs Directorate products, with further implementation details to follow.

Health Product Shortages in Canada: 2024-2025 Review

Health Canada has released its review of health product shortages for the 2024-2025 fiscal year. The report details drug and medical device shortages, including reporting requirements for manufacturers and highlights of high-impact cases. It notes a decrease in new drug shortage reports compared to the previous year.

Health Canada Proposes Reliance on Foreign Drug Authority Decisions

Health Canada is proposing a new Ministerial Reliance Order (MRO) that would allow the Minister to examine new drug submissions by relying on decisions from foreign regulatory authorities. This initiative is part of a broader Red Tape Review aimed at facilitating earlier drug availability in Canada while maintaining safety and quality standards. A 70-day consultation period is currently underway.

Health Canada Implements ICH Pharmaceutical Guidelines

Health Canada is implementing new International Council for Harmonisation (ICH) guidelines for pharmaceuticals, including M13A and Q12/Q14. These implemented ICH guidelines will take precedence over existing Health Canada guidance documents where discrepancies exist, potentially leading to amendments or withdrawals of current guidance.

HHS-Certified Laboratories for Urine/Oral Fluid Drug Testing

The Substance Abuse and Mental Health Services Administration (SAMHSA) has published the current list of HHS-certified laboratories and instrumented initial testing facilities for urine and oral fluid drug testing. This notice serves as an informational update for federal agencies and relevant parties.

SAMHSA Proposed Collection for Underage Drinking Prevention Activities

The Substance Abuse and Mental Health Services Administration (SAMHSA) has published a notice requesting public comment on a proposed collection of information related to underage drinking prevention activities. This notice initiates a 60-day comment period for interested parties.

SAMHSA Extends NSDUH Field Tests; Comment Deadline May 12

The Substance Abuse and Mental Health Services Administration (SAMHSA) has extended the field tests for the National Survey on Drug Use and Health (NSDUH). The agency is requesting public comments on this extension, with a deadline of May 12, 2026.

HSA Seizes Over $1.1M in Vaporisers

The Health Sciences Authority (HSA) seized over $1.1 million worth of vaporisers in an operation on February 24, 2026. New penalties under the Tobacco and Vaporisers Control Act (TVCA) will take effect from May 1, 2026, targeting importers, suppliers, and premises owners.

Colorado MMR Vaccine Reminder Program

The Colorado Department of Public Health and Environment is sending reminders to approximately 200,000 children who may be overdue for their MMR vaccine. This outreach is part of a routine public health program and occurs during a national surge in measles cases.

Colorado Identifies Additional Measles Cases

Colorado public health officials announced two additional measles cases in Broomfield County, with a third under investigation. The notice identifies a potential public exposure location and advises individuals to seek vaccination or medical consultation if exposed.

WHO Expert Committee on Specifications for Pharmaceutical Preparations 57th Report

The WHO Expert Committee on Specifications for Pharmaceutical Preparations has released its 57th report, recommending new and revised guidance texts for pharmaceutical quality assurance. These include updated GMP for excipients, new GMP for radiopharmaceutical cold kits, revised lab quality control practices, and updated biowaiver guidelines.

WHO Expert Committee on Pharmaceutical Preparations Meeting

The World Health Organization (WHO) announced the Sixtieth meeting of the Expert Committee on Specifications for Pharmaceutical Preparations, scheduled for October 12-16, 2026. This committee advises the Director-General on medicine quality assurance and the maintenance of The International Pharmacopoeia.

WHO Expert Committee on Biological Standardization Eightieth Report

The World Health Organization has published the eightieth report of its Expert Committee on Biological Standardization. This report details the proceedings and recommendations from the committee's meeting held in October 2024, focusing on the norms and standards for biological products.

WHO Expert Committee Adopts New Pharmaceutical Guidance

The WHO Expert Committee on Specifications for Pharmaceutical Preparations has adopted nine new guidance texts aimed at ensuring the quality assurance of medicines. These texts cover areas such as nitrosamine prevention, good manufacturing practices for excipients, and bioequivalence assessments, and are recommended for implementation.

DEA Announces 10,744 Arrests in DC Safety Initiative

The Drug Enforcement Administration (DEA) announced 10,744 arrests as part of an initiative to enhance safety in Washington D.C. The operation involved collaboration between local and federal law enforcement agencies, with the goal of removing illicit substances from communities.

EMA PRAC Warns of Aseptic Meningitis Risk with Ixchiq Vaccine

The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has recommended updating the product information for the chikungunya vaccine Ixchiq to reflect recent evidence of aseptic meningitis risk, particularly in healthy young adults. This follows a safety signal investigation and is part of a regular safety assessment.

FDA Report on Drug Shortage Prevention Efforts

The FDA has released its annual report to Congress detailing efforts in calendar year 2024 to prevent and mitigate drug shortages. The report highlights successful interventions that prevented 283 potential shortages, with only 15 new shortages identified.

FDA Drug Shortage Update

The FDA has updated its list of current and resolved drug shortages. The notice indicates 56 drugs are currently in shortage, 45 have been resolved, and 11 have been discontinued. This update provides a snapshot of the ongoing drug supply situation.

FDA Extends Drug Use Dates Due to Shortages

The FDA has extended the use dates for specific lots of certain drugs to help alleviate drug shortages. This guidance allows providers and patients to use these lots beyond their labeled expiration dates, based on manufacturer stability data. The agency is not requiring relabeling but expects replacement and disposal when new product becomes available.

DEA Seizes $600,000 from Semi-Truck Driver

The DEA Houston Division announced the seizure of over $600,000 from a semi-truck driver suspected of transporting funds for Mexican cartels. The seizure was a joint effort with the Department of Homeland Security (DHS).

DEA Reports 10,712 Arrests and Reduced Drug Availability

The DEA announced 10,712 arrests and a reduction in drug availability on the streets of Washington, D.C. This enforcement action, in coordination with other law enforcement agencies, aims to improve public safety and reduce crime.

FDA Novel Drug Approvals 2024

The FDA's Center for Drug Evaluation and Research (CDER) approved 50 novel drugs in 2024, representing new molecular entities never before marketed in the U.S. This notice provides a list of these approvals and links to detailed reports and drug information.

FDA Approves 5 New Novel Drugs in 2026

The FDA has announced the approval of five new novel drugs in 2026 for various medical conditions. These approvals include treatments for achondroplasia, hyperarginemia, schizophrenia, bipolar disorder, atopic dermatitis, and Menkes disease. The agency updated its list of novel drug therapy approvals.

FDA Novel Drug Approvals in 2022

The FDA's Center for Drug Evaluation and Research (CDER) approved 37 novel drugs in 2022, including new molecular entities (NMEs) and new therapeutic biological products (BLAs). This notice summarizes these approvals and provides a link to the full report.

FDA Novel Drug Approvals 2025

The FDA's Center for Drug Evaluation and Research (CDER) approved 46 novel drugs in 2025, meaning they were new and never before marketed in the U.S. The agency has released a report detailing these approvals, including drug names, active ingredients, and their approved uses.

FDA Novel Drug Approvals in 2023

The FDA's Center for Drug Evaluation and Research (CDER) approved 55 novel drugs in 2023, representing new therapies not previously marketed in the U.S. The agency released a report detailing these approvals and their uses.

AHRQ Press Releases on Patient Safety, Quality, and Research

The Agency for Healthcare Research and Quality (AHRQ) publishes press releases regarding patient safety, quality, and research. Recent releases cover topics such as a new dashboard for tracking patient harm reduction, reports on sepsis burden, and funding opportunities for state-based health improvement solutions.

AHRQ Stats: Healthcare Quality Statistics on Adverse Events, Maternal Deaths, Opioid Use

The Agency for Healthcare Research and Quality (AHRQ) has released updated statistics on healthcare quality. The data highlights adverse drug events involving hypoglycemic agents, disparities in healthcare expenditures by race/ethnicity, and maternal death rates by income and race/ethnicity.

AHRQ Impact Case Studies Highlight Evidence-Based Tools

The Agency for Healthcare Research and Quality (AHRQ) has published new impact case studies highlighting the use of its evidence-based tools and publications. These studies showcase how various healthcare organizations and policymakers have successfully implemented AHRQ resources to improve healthcare quality and safety.

AHRQ Social Media Presence Update

The Agency for Healthcare Research and Quality (AHRQ) has updated its social media presence, providing links to its official accounts on platforms including Instagram, Facebook, LinkedIn, and YouTube. This notice informs the public about where to find AHRQ research, tools, and training information online.

NIH Correction: Salary Limitation for Grants and Cooperative Agreements FY 2026

The National Institutes of Health (NIH) issued a correction to its guidance on salary limitations for grants and cooperative agreements for Fiscal Year 2026. The correction adjusts the effective date for the Executive Level II salary limitation of $228,000 from January 11, 2026, to January 1, 2026.

NIH Reminder: IRB Approval Certification Required Before Award

The National Institutes of Health (NIH) issued a notice reminding the extramural research community that certification of Institutional Review Board (IRB) approval is required before award for nonexempt human subjects research. Funds cannot be used for such research without this certification, which must be the date of final IRB approval, not pending or expired.

NIH Extends Common Forms Timeline for Biographical Sketch and Other Support

The National Institutes of Health (NIH) has extended the leniency period for implementing Common Forms for Biographical Sketch and Current and Pending (Other) Support until May 2026. This notice adjusts the original January 25, 2026 deadline to allow the extramural community more time for adoption and compliance.

NIH Removes Advanced Permission for Conference Grant Applications

The National Institutes of Health (NIH) has removed the requirement for advanced permission for conference grant applications under activity codes R13 and U13. This change aims to reduce administrative burden for applicants, with modifications to the NIH Grants Policy Statement and relevant NOFOs forthcoming.

HRSA Health Centers Served Record 32.4 Million Patients in 2024

The Health Resources and Services Administration (HRSA) announced that HRSA-funded health centers served a record 32.4 million patients in 2024. The data highlights quality improvements and recognizes nearly 1,000 health centers with Community Health Quality Recognition badges.

HRSA Lowers Out-of-Pocket Medication Costs at Health Centers

The Health Resources and Services Administration (HRSA) has issued updated award terms requiring HRSA-funded health centers to provide insulin and injectable epinephrine to low-income patients at or below the price paid by the center through the 340B Drug Pricing Program. This action aims to lower out-of-pocket costs for life-saving medications nationwide.

HRSA 340B Rebate Model Pilot Program Application and Comment Period

The Health Resources and Services Administration (HRSA) has announced a voluntary 340B Rebate Model Pilot Program for 2026 drugs. HRSA is seeking public comment on the application process for manufacturers and the pilot program itself, with a 30-day comment period.

HHS Settles HIPAA Breach Case with BST CPAs for $175,000

The U.S. Department of Health and Human Services (HHS) has settled a HIPAA breach case with BST & Co. CPAs, LLP for $175,000. The settlement resolves allegations that BST failed to conduct a risk analysis following a ransomware attack that impacted the protected health information of 170,000 individuals.

Deer Oaks HIPAA Resolution Agreement and Corrective Action Plan

The US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has entered into a Resolution Agreement and Corrective Action Plan with Deer Oaks, a covered entity under HIPAA. The agreement resolves allegations of impermissible disclosure of protected health information (PHI) and a subsequent data breach, requiring Deer Oaks to pay a resolution amount and implement corrective actions.

HHS - Syracuse ASC Pays $250,000 for HIPAA Violations

The U.S. Department of Health and Human Services (HHS) has reached a resolution agreement with Syracuse ASC, L.L.C. for violations of HIPAA Rules. Syracuse ASC will pay $250,000 and comply with a Corrective Action Plan to address failures in risk analysis and timely breach notifications.

MMG Fusion Settles HIPAA Violations for $10,000

The US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has reached a resolution agreement with MMG Fusion, LLC, a business associate handling protected health information (PHI). MMG Fusion will pay $10,000 to settle alleged violations of HIPAA's Privacy, Security, and Breach Notification Rules following a data breach that exposed patient information.

Comstar, LLC HIPAA Resolution Agreement and Corrective Action Plan

The US Department of Health and Human Services (HHS) has entered into a resolution agreement with Comstar, LLC, a business associate under HIPAA. Comstar will pay $75,000 and comply with a corrective action plan to resolve alleged violations of HIPAA's Privacy, Security, and Breach Notification Rules following a ransomware attack affecting 585,621 individuals.