Blog – Page 4 – PRAIS 2.0

PAHO calls for strengthened vaccination and surveillance amid the spread of antibiotic-resistant pertussis in the Americas

admin - 17:18, 25 de August de 2025121

PAHO calls for strengthened vaccination and surveillance amid the spread of antibiotic-resistant pertussis in the Americas

Cristina Mitchell

26 Aug 2025

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FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live). FDA Suspends Biologics License: FDA Safety Communication

Murilo Freitas - 04:00, 24 de August de 2025136

On August 22, 2025,the US FDA’s Center for Biologics Evaluation and Research has suspended the biologics license for Valneva Austria GmbH’s Ixchiq (Chikungunya Vaccine, Live). This vaccine was initially approved by FDA under the accelerated approval pathway in November of 2023 for the prevention of

http://www.fda.gov/safety/medical-product-safety-information/fda-update-safety-ixchiq-chikungunya-vaccine-live-fda-suspends-biologics-license-fda-safety

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Follow Instructions for Safe Use of Hyperbaric Oxygen Therapy Devices – Letter to Health Care Providers

Murilo Freitas - 04:00, 24 de August de 2025114

The FDA is reminding the public about the safe use of hyperbaric oxygen therapy devices and is providing recommendations to help reduce potential risks.

http://www.fda.gov/medical-devices/letters-health-care-providers/follow-instructions-safe-use-hyperbaric-oxygen-therapy-devices-letter-health-care-providers

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FDA Begins Real-Time Reporting of Adverse Event Data

Murilo Freitas - 15:46, 21 de August de 2025121

FDA Begins Real-Time Reporting of Adverse Event Data
http://www.fda.gov/news-events/press-announcements/fda-begins-real-time-reporting-adverse-event-data

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Latin American and Caribbean laboratories strengthen zoonotic influenza detection through joint PAHO-IAEA workshop

admin - 15:07, 21 de August de 2025174

Latin American and Caribbean laboratories strengthen zoonotic influenza detection through joint PAHO-IAEA workshop

Cristina Mitchell

22 Aug 2025

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Countries of the Americas advance toward regional strategy to tackle the health threat from venomous animal accidents

admin - 14:10, 21 de August de 2025167

Countries of the Americas advance toward regional strategy to tackle the health threat from venomous animal accidents

Cristina Mitchell

22 Aug 2025

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Vascular Stent Recall: Boston Scientific Removes Carotid WALLSTENT Monorail Endoprosthesis Due to Risk of Resistance During Device Withdrawal

Murilo Freitas - 04:00, 21 de August de 2025178

Boston Scientific Removes Carotid WALLSTENT Monorail Endoprosthesis due to risk of resistance during device withdrawal

http://www.fda.gov/medical-devices/medical-device-recalls/vascular-stent-recall-boston-scientific-removes-carotid-wallstent-monorail-endoprosthesis-due-risk

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HHS Allows FDA Emergency Use of Animal Drugs to Combat New World Screwworm, Protect U.S. Food Supply

Murilo Freitas - 12:45, 18 de August de 2025117

HHS Allows FDA Emergency Use of Animal Drugs to Combat New World Screwworm, Protect U.S. Food Supply
http://www.fda.gov/news-events/press-announcements/hhs-allows-fda-emergency-use-animal-drugs-combat-new-world-screwworm-protect-us-food-supply

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B. Braun Medical Issues Voluntary Nationwide Recall of Lactated Ringer’s Injection USP 1000 mL and 0.9% Sodium Chloride Injection USP 1000 mL Due to the Presence of Particulate Matter

Murilo Freitas - 04:00, 18 de August de 2025204

For Immediate Release – BETHLEHEM, PA – August 19, 2025 – B. Braun Medical Inc. (B. Braun) is voluntarily recalling two lots of Lactated Ringers Injection USP 1000 mL,and 0.9% Sodium Chloride Injection USP 1000 mL to the hospital level due to the presence of particulate matter inside the container.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/b-braun-medical-issues-voluntary-nationwide-recall-lactated-ringers-injection-usp-1000-ml-and-09