The FDA’s final guidance explains when drug companion apps may need review, labeling references or submissions to the agency.
FDA Issues Final Guidance On Prescription Drug Apps And Software
Browsing Category
Medication & Medical Management
183 posts
Early Alert: Cardinal Health Updates Use Instructions For Presource Packs Containing BD Alaris Pump Infusion Sets
The FDA says some Cardinal Health Presource kits may contain recalled BD Alaris infusion sets and details steps for health care customers.
More Medications, More Risks. If You’re Worried, Start A Deprescribing Discussion.
A rise in older adults taking five or more medications is prompting calls for medication reviews and patient-clinician discussions about deprescribing.
Where Can I Get An mRNA Flu Shot?
Moderna’s mFlusiva is available at more than 13,000 locations, but supply is limited. Check the company’s vaccine finder or call pharmacies.
Epilepsy Linked To Higher Risk Of Young-onset Dementia
A study in France and Sweden found an association between epilepsy and dementia diagnosed before 65, but does not show epilepsy causes dementia.
CVS To Pay $315M To Settle Justice Department Case Over Opioid Prescriptions
CVS and subsidiaries agreed to pay $315 million and add safeguards to settle a Justice Department lawsuit alleging unlawful opioid dispensing.
Drug-Eluting Intraocular Lens Passes Test In Patients With Cataracts And Glaucoma
A bimatoprost-releasing lens met noninferiority criteria against timolol drops for eye-pressure reduction in patients with cataracts and glaucoma.
Risks After Cataract, Glaucoma Surgery Tied To Higher Hemoglobin A1c Levels
Two AAO studies linked higher preoperative A1c with more macular edema after cataract surgery and higher infection risk after glaucoma shunt surgery.
Sutter Health Care Model Safely Expands Local Alzheimer’s Treatment
A Sutter Health review board helped community neurologists assess patients for Alzheimer’s drugs, with reported ARIA rates and safety caveats.
Infusion Set Recall: BD And CareFusion 303, Inc. Remove BD Alaris Pump Infusion Sets
The FDA says BD and CareFusion are removing certain Alaris infusion sets after updated testing found performance problems. No serious injuries or deaths were reported as of Aug. 19, 2026.
