Murilo Freitas – Page 37 – PRAIS 2.0

FDA Roundup: September 27, 2024

Murilo Freitas - 20:24, 26 de September de 2024438

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

FDA Approves Drug with New Mechanism of Action for Treatment of Schizophrenia

Murilo Freitas - 22:40, 25 de September de 2024337

FDA Approves Drug with New Mechanism of Action for Treatment of Schizophrenia
http://www.fda.gov/news-events/press-announcements/fda-approves-drug-new-mechanism-action-treatment-schizophrenia

Zimmer Biomet CPT Hip System Femoral Stem and Increased Risk of Thigh Bone Fracture – FDA Safety Communication

Murilo Freitas - 04:00, 25 de September de 2024295

Read the FDA’s recommendations related to the Zimmer Biomet CPT Hip System and increased risk of thigh bone fracture.

http://www.fda.gov/medical-devices/safety-communications/zimmer-biomet-cpt-hip-system-femoral-stem-and-increased-risk-thigh-bone-fracture-fda-safety

FDA Approves New Drug to Treat Niemann-Pick Disease, Type C

Murilo Freitas - 21:30, 23 de September de 2024277

FDA Approves New Drug to Treat Niemann-Pick Disease, Type C
http://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-treat-niemann-pick-disease-type-c

FDA Roundup: September 24, 2024

Murilo Freitas - 20:07, 23 de September de 2024265

FDA Roundup: September 24, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-september-24-2024

Compounding Device Inlet Correction: Baxter Healthcare Corporation Updates Use Instructions for Exactamix Automated Compounding Device Inlets due to Risk for Particulate Matter in Device Components

Murilo Freitas - 04:00, 23 de September de 2024377

Automated Compounding Device Inlets used with Exactamix Compounding Devices may contain particulate matter that poses a risk to patients.

http://www.fda.gov/medical-devices/medical-device-recalls/compounding-device-inlet-correction-baxter-healthcare-corporation-updates-use-instructions-exactamix

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Gilead Issues Voluntary Nationwide Recall of One Lot of Veklury (Remdesivir) for Injection 100 mg/vial Due to the Presence of a Glass Particle

Murilo Freitas - 04:00, 22 de September de 20243,584

Foster City, Calif., September 20, 2024 – Gilead Sciences, Inc. (Nasdaq: GILD) today announced it is issuing a voluntary recall of one lot of Veklury® (remdesivir) for Injection 100 mg/vial, to the consumer level. Gilead received a customer complaint and confirmed the presence of a glass particle in

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gilead-issues-voluntary-nationwide-recall-one-lot-veklury-remdesivir-injection-100-mgvial-due

Electrode Pad Correction: Megadyne Issues Correction for MEGA SOFT, MEGA SOFT DUAL and MEGA 2000 Patient Return Electrodes to Limit Risk of Pediatric Burns

Murilo Freitas - 04:00, 22 de September de 2024313

MEGA SOFT and MEGA 2000 Patient Return Electrodes used during monopolar electrosurgery may cause serious patient burn injuries.

http://www.fda.gov/medical-devices/medical-device-recalls/electrode-pad-correction-megadyne-issues-correction-mega-soft-mega-soft-dual-and-mega-2000-patient

FDA Roundup: September 20, 2024

Murilo Freitas - 19:10, 19 de September de 2024338

FDA Roundup: September 20, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-september-20-2024

FDA Approves Nasal Spray Influenza Vaccine for Self- or Caregiver-Administration

Murilo Freitas - 15:47, 19 de September de 2024452

FDA Approves Nasal Spray Influenza Vaccine for Self- or Caregiver-Administration
http://www.fda.gov/news-events/press-announcements/fda-approves-nasal-spray-influenza-vaccine-self-or-caregiver-administration

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