FDA Warns of Cybersecurity Risk With Certain Medtronic Insulin Pumps
Equipment issue may allow someone to break in and cause the pump to deliver too much or too little insulin to the patient.
FDA
FDA Admits Flaws in Response to Infant Formula Shortage
Problems highlighted in report include outdated data-sharing systems, below-normal staffing and training for food inspectors.
FDA Panel Meeting Scheduled to Discuss Rx-to-OTC Switch of Oral Contraceptive Opill
Opill contains 0.075 mg of norgestrel, a single active steroid ingredient.
Top August 2022 FDA Approvals
August 2022 FDA approvals include treatments for chronic idiopathic constipation, major depressive disorder, and testosterone replacement therapy.
FDA Warns of Rare Cases of Certain Cancers Linked to Breast Implants
There have been fewer than 20 cases of squamous cell carcinoma and fewer than 30 cases of various lymphomas reported in the capsule around breast implants.
Top May & June 2022 FDA Approvals
May and June 2022 FDA approvals include treatments from alopecia areata, H. pylori, Crohn disease, plaque psoriasis, and Wilson disease.
FDA Pulls Plug on JUUL Products
The US Food and Drug Administration has issued marketing denial orders to JUUL Labs, essentially pulling the plug on JUUL vaping products.
FDA Approves Skyrizi for Moderately to Severely Active Crohn Disease
Skyrizi is first specific interleukin-23 approved to treat Crohn disease.
Olumiant Approved for Severe Alopecia Areata
The approval was based on data from the phase 2/3 BRAVE-AA1 and phase 3 BRAVE-AA2 trials, which included adults with severe alopecia areata.
FDA Aims To Improve Medical Device Security
The agency has issued proposed draft recommendations to guide incorporation of cybersecurity protections into medical devices at the time of manufacture.
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