The latest headlines across every section, pulled from official and open-access sources.
July - September 2025 | New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)
Dexcom, Abbott, MiniMed and Insulet featured upcoming technologies at the American Diabetes Association’s annual event. Catch up on news coming out of the conference.
The stroke treatment could contribute about $100 million in incremental revenue over time to Boston Scientific, the buyer of Penumbra, one analyst said.
For Physicians: A Guide to Non-emergency Single Patient Expanded Access Submissions webpage describes the four initial steps to initiating a request for single patient expanded access in a non-emergency situation. Subsequent submissions are also described. Links are available for more information.
Information is intended to provide an overview of timelines applicable to physicians who plan to submit or have submitted individual patient expanded access applications for emergency use.
IND Application Reporting: Safety Reports
The Office of Generic Drugs requested manufacturers of sixteen look-alike name pairs to voluntarily revise the appearance of their established names in order to minimize medication errors resulting from look-alike confusion.
Regulatory Perspectives on Herbal Medicinal/Botanical Drug Product Development – Joint FDA/EMA Workshop
As with any medicine, the MHRA will keep the safety and effectiveness of the adrenaline nasal spray under close review.
by Eric Jauniaux, Helena C. Bartels, Yalda Afshar Placenta accreta spectrum (PAS) is a serious pregnancy complication caused by abnormal placental attachment to the uterus. In this Perspective, Eric Jauniaux and colleagues discuss emerging evidence that challenges our long-held pathophysiological understanding of PAS, and argue that a critical reassessment of definition, diagnosis, and management is overdue. In this Perspective, Jonathan Evans and colleagues discuss why restricting access to joint replacement surgery based on BMI alone is not supported by evidence, and highlight how such rest…
by Gabriella C. Silva, Aurore Fayosse, Louis Jacob, Séverine Sabia, Archana Singh-Manoux, Benjamin Landré Background Multimorbidity, the presence of several chronic conditions, is linked to higher mortality and healthcare use and thus poses a major challenge for aging populations. While most studies rely on simple counts of conditions, clustering approaches have been proposed to describe patterns of co-occurring diseases. We aimed to evaluate the extent to which these methodological choices influence prevalence and association with health profiles and mortality. Methods and findings Using UK…
ACP members met with members of Congress to discuss the importance of physician engagement and protecting patients' access to care.
FDA's Drug Competition Action Plan (DCAP) encourages robust and timely market competition for generic drugs and helps bring greater efficiency and transparency to the generic drug review process, without sacrificing the scientific rigor underlying our generic drug program.
Winning in health-tech is about giving buyers enough operational clarity, early enough, that they can say yes with confidence rather than saying yes because the alternative is another six months of the same evaluation cycle. The post Stop Presenting at Health-Tech Buyers — Let Them Drive appeared first on MedCity News .
Insecurity about transportation can lead to missed appointments and delayed care, and obstacles are more common for cancer patients than for the general population. The post Reliable Transportation Isn’t a Luxury — It’s an Important Part of Cancer Care appeared first on MedCity News .
Healthcare organizations across the country are committed to improving health equity—but many struggle with a fundamental question: how do you measure progress in a meaningful, actionable way? A new resource, Cracking the Code: A Health Equity Analytics Implementation Playbook for Healthcare Organizations, helps answer that question. The playbook offers a structured, practical approach for using […] The post Turning Data Into Action: A Playbook for Advancing Health Equity appeared first on NCQA .
Forms FDA 3542a and FDA 3542: Questions and Answers
Guidance documents represent the FDA's current thinking on a particular subject. New guidance documents are listed here for three months.
New data from the World Health Organization (WHO) show sustained progress towards safer blood supplies globally but also highlight persistent inequalities in access to safe blood and weaknesses in governance, financing and regulation of blood systems.
Official statistics in development on insights from client level data from local authorities, including information on assessments and long-term support.
PRAC concludes evidence of potential risk of neurodevelopmental disorders in children born to men treated with valproate is inconsistent Committee recommends updating product…, Agenda Agenda of the PRAC meeting 8-11 June 2026Draft Reference Number: EMA/PRAC/115322/2026…, PRAC statistics: June 2026 , , Glossary Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association between…
Official statistics in development on insights from client level data from local authorities, including information on assessments and long-term support.
Directions for the NHS from the Secretary of State for Health and Social Care relating to Alternative Provider Medical Services (APMS) contracts in general practice.
These previous directions, published for public reference, were for the NHS from the Secretary of State for Health and Social Care and relate to APMS contracts in general practice.