Murilo Freitas – Page 2 – PRAIS 2.0

FDA Eliminates Major Barrier to Using Real-World Evidence in Drug and Device Application Reviews

Murilo Freitas - 17:55, 14 de December de 2025316

FDA Eliminates Major Barrier to Using Real-World Evidence in Drug and Device Application Reviews
http://www.fda.gov/news-events/press-announcements/fda-eliminates-major-barrier-using-real-world-evidence-drug-and-device-application-reviews

FDA Proactively Awards National Priority Voucher Based on Strong Phase 3 Study Results

Murilo Freitas - 15:03, 14 de December de 202593

FDA Proactively Awards National Priority Voucher Based on Strong Phase 3 Study Results
http://www.fda.gov/news-events/press-announcements/fda-proactively-awards-national-priority-voucher-based-strong-phase-3-study-results

FDA Approves Two Oral Therapies to Treat Gonorrhea

Murilo Freitas - 18:17, 11 de December de 202561

FDA Approves Two Oral Therapies to Treat Gonorrhea
http://www.fda.gov/news-events/press-announcements/fda-approves-two-oral-therapies-treat-gonorrhea

FDA Proposes Expanding Sunscreen Active Ingredient List

Murilo Freitas - 13:20, 10 de December de 202551

FDA Proposes Expanding Sunscreen Active Ingredient List
http://www.fda.gov/news-events/press-announcements/fda-proposes-expanding-sunscreen-active-ingredient-list

Early Alert: Anesthesia System Issue from GE HealthCare

Murilo Freitas - 05:00, 9 de December de 2025220

GE HealthCare issues updated use instructions for certain Carestation 600 and 700 series Anesthesia Systems

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-anesthesia-system-issue-ge-healthcare

MediNatura New Mexico, Inc. Issues Voluntary Nationwide Recall of ReBoost Nasal Spray Due to Microbial Contamination

Murilo Freitas - 05:00, 9 de December de 2025357

FOR IMMEDIATE RELEASE – December 10, 2025 – Albuquerque, New Mexico, MediNatura New Mexico, Inc. is voluntarily recalling one lot of ReBoost Nasal Spray to the consumer level. The product has been found to contain yeast/mold and microbial contamination with one species identified as Achromobacter, a

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/medinatura-new-mexico-inc-issues-voluntary-nationwide-recall-reboost-nasal-spray-due-microbial

FDA Approves First Gene Therapy Treatment for Wiskott-Aldrich Syndrome

Murilo Freitas - 22:45, 8 de December de 2025179

FDA Approves First Gene Therapy Treatment for Wiskott-Aldrich Syndrome
http://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapy-treatment-wiskott-aldrich-syndrome

First Approval in Commissioner’s National Priority Voucher Pilot Program Strengthens Domestic Antibiotic Manufacturing Capacity

Murilo Freitas - 21:28, 8 de December de 2025132

First Approval in Commissioner’s National Priority Voucher Pilot Program Strengthens Domestic Antibiotic Manufacturing Capacity

http://www.fda.gov/news-events/press-announcements/first-approval-commissioners-national-priority-voucher-pilot-program-strengthens-domestic-antibiotic

FDA Approves First Cellular Therapy to Treat Patients with Severe Aplastic Anemia

Murilo Freitas - 18:02, 7 de December de 202583

FDA Approves First Cellular Therapy to Treat Patients with Severe Aplastic Anemia
http://www.fda.gov/news-events/press-announcements/fda-approves-first-cellular-therapy-treat-patients-severe-aplastic-anemia

FDA Launches TEMPO: A First-of-Its-Kind Digital Health Pilot to Expand Access to Chronic Disease Technologies

Murilo Freitas - 20:15, 4 de December de 2025557

FDA Launches TEMPO: A First-of-Its-Kind Digital Health Pilot to Expand Access to Chronic Disease Technologies
http://www.fda.gov/news-events/press-announcements/fda-launches-tempo-first-its-kind-digital-health-pilot-expand-access-chronic-disease-technologies

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