Blog – Page 6 – PRAIS 2.0

A Statement from FDA Commissioner Marty Makary, M.D., M.P.H.: Announcing Resolution of the IV Saline Solutions Shortage

Murilo Freitas - 15:25, 7 de August de 202580

A Statement from FDA Commissioner Marty Makary, M.D., M.P.H.: Announcing Resolution of the IV Saline Solutions Shortage
http://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-marty-makary-md-mph-announcing-resolution-iv-saline-solutions-shortage

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FDA Announces New FDA PreCheck Program to Boost U.S. Drug Manufacturing

Murilo Freitas - 13:32, 6 de August de 202592

FDA Announces New FDA PreCheck Program to Boost U.S. Drug Manufacturing
http://www.fda.gov/news-events/press-announcements/fda-announces-new-fda-precheck-program-boost-us-drug-manufacturing

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La OMS designa nuevas autoridades para su inclusión en la lista de autoridades catalogadas por la OMS, lo que refuerza el acceso mundial a productos médicos de calidad garantizada

admin - 13:21, 6 de August de 2025111

WHO designates new WHO-Listed Authorities, strengthening global access to quality-assured medical products

Cristina Mitchell

7 Aug 2025

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FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live): FDA Safety Communication

Murilo Freitas - 04:00, 6 de August de 2025114

FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live). FDA Removes Recommended Pause in Use and Approves Required Updated Labeling: FDA Safety Communication

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

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On World Breastfeeding Week, countries urged to invest in health systems and support breastfeeding mothers

admin - 21:33, 5 de August de 2025105

On World Breastfeeding Week, countries urged to invest in health systems and support breastfeeding mothers

Oscar Reyes

6 Aug 2025

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PAHO presents its 2024 country reports, highlighting concrete results of its technical cooperation in health in the Americas

admin - 18:27, 5 de August de 202594

PAHO presents its 2024 country reports, highlighting concrete results of its technical cooperation in health in the Americas

Oscar Reyes

6 Aug 2025

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Early Alert: Defibrillation Lead Issue from Boston Scientific

Murilo Freitas - 04:00, 5 de August de 202583

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

http://www.fda.gov/medical-devices/medical-device-recalls/early-alert-defibrillation-lead-issue-boston-scientific

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Early Alert: Electrophysiology Catheter Issue from Medline ReNewal

Murilo Freitas - 04:00, 5 de August de 202596

Recall affects certain Medline ReNewal Reprocessed St. Jude Medical Response Diagnostic Electrophysiology Catheters and Supreme Electrophysiology Catheters

http://www.fda.gov/medical-devices/medical-device-recalls/early-alert-electrophysiology-catheter-issue-medline-renewal

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Early Alert: WATCHMAN Access System Issue from Boston Scientific

Murilo Freitas - 04:00, 5 de August de 202598

Boston Scientific has issued a letter to affected customers recommending all lots of certain WATCHMAN Access Systems have updated use instructions

http://www.fda.gov/medical-devices/medical-device-recalls/early-alert-watchman-access-system-issue-boston-scientific

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Continuous Ventilator Correction: Philips Respironics Updates Use Instructions for BiPAP A30, A40, and V30 Devices Due to Interruptions and/or Loss of Therapy

Murilo Freitas - 04:00, 5 de August de 2025105

BiPAP A30, A40, and V30 devices may shut down due to a Ventilator Interruptions, leading to therapy loss. May cause serious injury or death.

http://www.fda.gov/medical-devices/medical-device-recalls/continuous-ventilator-correction-philips-respironics-updates-use-instructions-bipap-a30-a40-and-v30