FDA Pulls Surgical Mesh for Pelvic Organ Prolapse From the Market
The agency alleges manufacturers failed to provide evidence of the long-term safety of surgical mesh for transvaginal repair of anterior compartment prolapse.
FDA
FDA Investigating Paclitaxel Balloons and Stents
Investigation triggered by meta-analysis showing possible increased mortality in PAD patients at 2 years
FDA Down to 5 Weeks of Funding to Review New Drug Applications
Agency cannot accept new fees or applications until the shutdown is over
FDA: Fluoroquinolones Tied to Heart Vessel Ruptures, Tears
Patients at risk include those with hypertension or certain genetic disorders and the elderly
Xyosted Now Available for Treatment of Testosterone Deficiency
Prior to starting Xyosted, the patient’s baseline cardiovascular risk should be considered and blood pressure should be adequately controlled.
FDA to Update Medical Device Approvals Process
Revised process will ensure new medical devices meet safety and effectiveness standards
Men Should Avoid ‘Rhino’ Sexual Enhancement Products, FDA Says
Reports include chest pain, severe headaches, prolonged erections after taking Rhino products.
FDA Approves Vitrakvi for Cancers With Certain Genetic Trait
Drug targets solid tumors with NTRK gene fusion without a known acquired resistance mutation
FDA Recalls Drugs Containing Active Ingredient Valsartan
All lots of non-expired products that contain valsartan supplied by Zhejiang Huahai being recalled.
Trials Supporting FDA Approval of Breakthrough Drugs Examined
Pivotal trials supporting these approvals often lack randomization, double-blinding, control groups.
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