The latest headlines across every section, pulled from official and open-access sources.
The Food and Drug Administration (FDA or the Agency) is announcing its annual public meeting and opportunity for public comment on “Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments.”
Over the years, FDA has worked to increase communication between Agency staff and applicants during the review of novel drug and original biologic applications. The goal has been to enhance the transparency, predictability, effectiveness, and efficiency of the review process.
This public meeting is intended to meet performance commitments included in PDUFA VI, BsUFA II, and GDUFA II.
The US. Food and Drug Administration (FDA) in collaboration with the Health and Environmental Sciences Institute (HESI), and the Safety Pharmacology Society (SPS) will host a hybrid public workshop entitled “ICH S7A and New Approach Methodologies (NAMs) in Safety Pharmacology” on July 28, 2026.
FRANKLIN LAKES, N.J. (June 06, 2026) – BD (Becton, Dickinson and Company) is voluntarily recalling lot 4032183 of ChloraPrep™ Clear 1 mL Single Sterile and lot 4073005 of FREPP™ Clear 1.5 mL applicators with paper lidding to the consumer level. These products are being recalled due to fungal contami
Tandem Diabetes Care, Insulet and Dexcom all presented data over the weekend at the American Diabetes Association’s Scientific Sessions.
Knowledge and Library Services provide a range of information skills training for eligible staff. Training is available in group or one-to-one settings.
FDA has received reports that the use of Mavyret, Zepatier, or Vosevi to treat chronic Hepatitis C in patients with moderate to severe liver impairment has resulted in rare cases of worsening liver function or liver failure.
Cyanotic congenital heart diseases occur in approximately 0.2% of live births in the US, but survival to adulthood is common with current surgical interventions. JAMA Associate Editor David Simel, MD, MHS, speaks with author Michael Landzberg, MD, who coauthored a recent review in JAMA on this topic. Related Content: Survivors of Cyanotic Congenital Heart Disease
The agency continues to prioritize the speed and efficiency with which generic drugs are regulated, while balancing the need for minimizing risk and ensuring access to quality medications.
Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)
The planned logistics site, near a principal manufacturing facility, will handle global distribution of Boston Scientific’s medical devices.
Policy Lab worked with the Department of Health and Social Care to develop a co-design toolkit enabling parents and carers to shape early years services.
By fine-tuning domain-specific models with real clinical operations data — such as historical performance, feasibility outcomes, enrollment patterns, and resource utilization — hidden information can be translated into structured intelligence. The post How AI is Unlocking Smarter Clinical Trial Protocols appeared first on MedCity News .
NCQA seeks feedback on a new Accreditation for Advanced Primary Care and updates to Health Plan Accreditation. Reviewers can submit comments to NCQA in writing via the Public Comment website by 11:59 p.m. (ET), Friday, July 10. About NCQA’s Public Comment NCQA releases program updates for public comment to generate thoughtful feedback and suggestions from […] The post Public Comment Is Open! Share Your Feedback on a New Accreditation for Advanced Primary Care and Updates to Health Plan Accreditation appeared first on NCQA .
Decisions made by MHRA on adverts reported to have breached the legislation on advertising medicines.
Supply chain resilience is far too important to leave with the supply chain specialists. Health systems must elevate the resilience issue to the corporate strategy level and involve officers from other functional areas as well. The post 6 Ways in Which Healthcare Needs to Expand the Supply Chain Resilience Conversation appeared first on MedCity News .
While the policy changes create new opportunities, they also introduce operational complexity. Here’s some important things to know. The post Expanding the Reach of Remote Patient Monitoring: The Real Signal Behind the 2026 RPM Changes appeared first on MedCity News .
This workshop provides an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives. Learn more.
How is a medicine approved by FDA?, How can I find out if my medicine is approved by FDA?
A generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use.
Guidance on the various types of modifications that can be made to a clinical trial approval.
CDER Leadership Bios
Since April 2012, and as of 1 June 2026, a total of 2 649 MERS cases, including 960 deaths, have been reported by health authorities worldwide.