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FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled Medical Devices

Murilo Freitas - 15:16, 5 de January de 202550

FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled Medical Devices
http://www.fda.gov/news-events/press-announcements/fda-issues-comprehensive-draft-guidance-developers-artificial-intelligence-enabled-medical-devices

FDA Roundup: January 3, 2025

Murilo Freitas - 19:19, 2 de January de 202560

FDA Roundup: January 3, 2025
http://www.fda.gov/news-events/press-announcements/fda-roundup-january-3-2025

Early Alert: Solution Set Issue from Baxter Healthcare Corporation

Murilo Freitas - 05:00, 30 de December de 202455

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-solution-set-issue-baxter-healthcare-corporation

Early Alert: Extracorporeal Blood Circuit Issue from Nuwellis

Murilo Freitas - 05:00, 29 de December de 202455

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-extracorporeal-blood-circuit-issue-nuwellis

Early Alert: Fluid Delivery Set Issue from Medline

Murilo Freitas - 05:00, 29 de December de 202460

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-fluid-delivery-set-issue-medline

FDA Roundup: December 27, 2024

Murilo Freitas - 20:22, 26 de December de 202452

FDA Roundup: December 27, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-december-27-2024

FDA Proposes Rule to Require Standardized Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products

Murilo Freitas - 17:08, 25 de December de 202450

FDA Proposes Rule to Require Standardized Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products
http://www.fda.gov/news-events/press-announcements/fda-proposes-rule-require-standardized-testing-methods-detecting-and-identifying-asbestos-talc

Astellas Pharma US, Inc. Issues Voluntary Nationwide Recall of One Lot of PROGRAF® 0.5mg (Tacrolimus) and One Lot of ASTAGRAF XL® 0.5mg (Tacrolimus Extended-Release Capsules) Because Bottles Shipped to U.S. May Contain Empty Capsules

Murilo Freitas - 05:00, 23 de December de 202460

Astellas Pharma US, Inc. (Head of US Commercial: Michael Petroutsas, “Astellas”) is voluntarily recalling one lot of PROGRAF® 0.5mg (tacrolimus) and one lot of ASTAGRAF XL® 0.5mg (tacrolimus extended-release) capsules to the consumer level. These products are being recalled because bottles may conta

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/astellas-pharma-us-inc-issues-voluntary-nationwide-recall-one-lot-prografr-05mg-tacrolimus-and-one

PAHO urges protection of medical facilities and services in Haiti to ensure continued access amid escalating conflict

admin - 17:06, 22 de December de 202450

PAHO urges protection of medical facilities and services in Haiti to ensure continued access amid escalating conflict

Oscar Reyes

23 Dec 2024

FDA Approves First Generic of Once-Daily GLP-1 Injection to Lower Blood Sugar in Patients with Type 2 Diabetes

Murilo Freitas - 16:24, 22 de December de 202455

FDA Approves First Generic of Once-Daily GLP-1 Injection to Lower Blood Sugar in Patients with Type 2 Diabetes
http://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-once-daily-glp-1-injection-lower-blood-sugar-patients-type-2-diabetes

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