rss – PRAIS 2.0

FDA Approves New Safety Warning and Revised Indication that Limits Use for Elevidys Following Reports of Fatal Liver Injury

Murilo Freitas - 18:44, 13 de November de 202522

FDA Approves New Safety Warning and Revised Indication that Limits Use for Elevidys Following Reports of Fatal Liver Injury
http://www.fda.gov/news-events/press-announcements/fda-approves-new-safety-warning-and-revised-indication-limits-use-elevidys-following-reports-fatal

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Update: FDA Encourages the Public to Follow Established Choking Rescue Protocols – FDA Safety Communication

Murilo Freitas - 05:00, 12 de November de 202524

These choking rescue protocols include abdominal thrusts (also called the “Heimlich” maneuver) for children and adults but not anti-choking devices.

http://www.fda.gov/medical-devices/safety-communications/update-fda-encourages-public-follow-established-choking-rescue-protocols-fda-safety-communication

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Longtime FDA Innovator Appointed as Director of Center for Drug Evaluation and Research

Murilo Freitas - 21:19, 10 de November de 202535

Longtime FDA Innovator Appointed as Director of Center for Drug Evaluation and Research
http://www.fda.gov/news-events/press-announcements/longtime-fda-innovator-appointed-director-center-drug-evaluation-and-research

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HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy

Murilo Freitas - 17:17, 9 de November de 202524

HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy
http://www.fda.gov/news-events/press-announcements/hhs-advances-womens-health-removes-misleading-fda-warnings-hormone-replacement-therapy

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Fresenius Kabi Issues Voluntary Nationwide Recall of Three Lots of Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL Fill in a 2 mL Vial Due to Out-of-Specification Endotoxin Results in Certain Reserve Samples

Murilo Freitas - 05:00, 6 de November de 202544

FOR IMMEDIATE RELEASE – Nov. 6,2025 – LAKE ZURICH, Ill.— Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies is voluntarily recalling three lots (numbers 6133156, 6133194, 6133388) of Famotidine Injection, USP, 20 mg

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-voluntary-nationwide-recall-three-lots-famotidine-injection-usp-20-mg-2-ml-10

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FDA Awards Second Batch of National Priority Vouchers

Murilo Freitas - 18:49, 5 de November de 202546

FDA Awards Second Batch of National Priority Vouchers
http://www.fda.gov/news-events/press-announcements/fda-awards-second-batch-national-priority-vouchers

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FDA Warns Companies Over Illegal Marketing of Botox and Related Products

Murilo Freitas - 18:44, 4 de November de 202538

FDA Warns Companies Over Illegal Marketing of Botox and Related Products
http://www.fda.gov/news-events/press-announcements/fda-warns-companies-over-illegal-marketing-botox-and-related-products

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Olympus Issues Voluntary Labeling Update for Bronchoscopes Used with Laser Therapy Equipment

Murilo Freitas - 05:00, 2 de November de 202553

CENTER VALLEY, Pa., (October 31, 2025) – Olympus Corporation has announced a voluntary, global medical device corrective action to provide further clarification on the safe and effective use of bronchoscopes with laser therapy, argon plasma coagulation or high-frequency cauterization equipment durin

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/olympus-issues-voluntary-labeling-update-bronchoscopes-used-laser-therapy-equipment

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Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 20 mEq Potassium Chloride Injection Due To Overwrap Mislabeled As 10 mEq Potassium Chloride Injection

Murilo Freitas - 05:00, 2 de November de 202545

FOR IMMEDIATE RELEASE – October 31, 2025 AUSTIN, TX – Otsuka ICU Medical LLC is issuing a voluntary recall to the user level, for a MISLABELLED lot of POTASSIUM CHLORIDE Inj. 20 mEq, NDC 0990-7077-14. The OVERWRAP label of lot 1030613, Expiration Date: 09-30-2026 may incorrectly identify the product

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/otsuka-icu-medical-llc-issues-voluntary-nationwide-recall-20-meq-potassium-chloride-injection-due

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FDA Acts to Protect Children from Unapproved Fluoride Drug Products

Murilo Freitas - 17:01, 30 de October de 202546

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