rss – PRAIS 2.0

FDA Acts to Protect Children from Unapproved Fluoride Drug Products

Murilo Freitas - 17:01, 30 de October de 202520

FDA Acts to Protect Children from Unapproved Fluoride Drug Products
http://www.fda.gov/news-events/press-announcements/fda-acts-protect-children-unapproved-fluoride-drug-products

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Hintermann Series H3 Total Ankle Replacement Has a Higher-Than-Expected Risk of Device Failure: FDA Safety Communication

Murilo Freitas - 04:00, 30 de October de 202521

Learn more about recommendations for patients who are considering a Hintermann Series H3 TAR system or who have one; recommendations for health care providers.

http://www.fda.gov/medical-devices/safety-communications/hintermann-series-h3-total-ankle-replacement-has-higher-expected-risk-device-failure-fda-safety

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FDA Moves to Accelerate Biosimilar Development and Lower Drug Costs

Murilo Freitas - 17:01, 28 de October de 202525

FDA Moves to Accelerate Biosimilar Development and Lower Drug Costs
http://www.fda.gov/news-events/press-announcements/fda-moves-accelerate-biosimilar-development-and-lower-drug-costs

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FDA Issues Emergency Use Authorization for New World Screwworm Drug for Dogs

Murilo Freitas - 20:31, 23 de October de 202532

FDA Issues Emergency Use Authorization for New World Screwworm Drug for Dogs
http://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-new-world-screwworm-drug-dogs

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FDA Publishes Filing Checklists to Prevent Submission Delays

Murilo Freitas - 14:35, 22 de October de 202541

FDA Publishes Filing Checklists to Prevent Submission Delays
http://www.fda.gov/news-events/press-announcements/fda-publishes-filing-checklists-prevent-submission-delays

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FDA Awards First-Ever National Priority Vouchers to Nine Sponsors

Murilo Freitas - 20:57, 15 de October de 202570

FDA Awards First-Ever National Priority Vouchers to Nine Sponsors
http://www.fda.gov/news-events/press-announcements/fda-awards-first-ever-national-priority-vouchers-nine-sponsors

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Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling – FDA Safety Communication

Murilo Freitas - 04:00, 14 de October de 2025109

FDA is aware of serious complications reported with certain uses of radiofrequency microneedling devices; asks for reports of injuries related these devices

http://www.fda.gov/medical-devices/safety-communications/potential-risks-certain-uses-radiofrequency-rf-microneedling-fda-safety-communication

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Alert: Automated Impella Controller Correction due to Cybersecurity Issue from Abiomed

Murilo Freitas - 04:00, 9 de October de 202580

Abiomed has issued a letter to affected customers of cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/alert-automated-impella-controller-correction-due-cybersecurity-issue-abiomed

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FDA Approves Labeling Changes that Include a Boxed Warning for Immune Effector Cell-associated Enterocolitis Following Treatment with Ciltacabtagene Autoleucel (CARVYKTI, Janssen Biotech, Inc.)

Murilo Freitas - 04:00, 9 de October de 202580

The FDA has received reports of immune effector cell-associated enterocolitis (IEC-EC) in patients who received treatment with CARVYKTI.

http://www.fda.gov/safety/medical-product-safety-information/fda-approves-labeling-changes-include-boxed-warning-immune-effector-cell-associated-enterocolitis

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Trividia Health, Inc. Initiates Voluntary Recall of Limited Number of TRUE METRIX® Blood Glucose Meters

Murilo Freitas - 04:00, 6 de October de 202587

(FT. LAUDERDALE, FL) –October 7, 2025 – Trividia Health, Inc., announced today that it is initiating a voluntary recall of a limited number of TRUE METRIX® Self-Monitoring Blood glucose meters co-branded under the Good Neighbor Pharmacy® brand and distributed in the United States.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/trividia-health-inc-initiates-voluntary-recall-limited-number-true-metrixr-blood-glucose-meters