Apotex Inc. – 05/09/2025
Apotex Inc. – 05/09/2025. Country: Canada. Record Type: 483
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Early Alert: Glucose Monitor Sensor Issue from Abbott Diabetes Care
Certain Abbott Diabetes Care Continuous Glucose Monitor sensors may provide incorrect low glucose readings -
FarmaKeio Outsourcing LLC. Southlake, TX. 483 issued 09/05/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 09/05/2025
Short Title (70 char) FarmaKeio Outsourcing LLC. Southlake, TX. 483 issued 09/05/2025
FEI Number 3014982757
Firm Name FarmaKeio Outsourcing LLC
Record Type 483
State TX
Establishment Type Outsourcing -
MHRA approves tisotumab vedotin for the treatment of cervical cancer
As with all licensed medicines, we will continue to monitor its safety closely as it becomes more widely used
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Promotional material: Vaccine safety – patient factsheet
Patient factsheet to provide information on vaccines and vaccine safety.
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Monoclonal Antibodies: Streamlined Nonclinical Safety Studies
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Monoclonal Antibodies: Streamlined Nonclinical Safety Studies.” -
Guidance: Centres of Excellence for Regulatory Science and Innovation (CERSIs)
An initiative to help drive advancements in healthcare, to ensure patients benefit from innovation and new treatments sooner.
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Field Safety Notices: 24 to 28 November 2025
List of Field Safety Notices from 24 to 28 November 2025.
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Recall Alert: Glycar SA Removes Pericardial Patch
Certain SJM Pericardial Patches from Glycar SA may not meet the required tensile strength specification -
What You Should Know about Eye Drops
Ophthalmic drug products, such as eye drops, pose a heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses. Any drug used in the eyes must be sterile to reduce the risk of infection. Eye drops are available by prescription or sold as OTCs. -
Patient-Focused Drug Development
The OCE PFDD program fosters collaboration between FDA centers and external stakeholders involved in patient outcomes research in cancer populations. -
FDA Approves First Drug to Treat Agitation Symptoms Associated with Dementia due to Alzheimer’s Disease
The FDA granted supplemental approval to Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer’s disease. This is the first FDA-approved treatment option for this indication.