FDA Launches New Program to Accelerate Meeting Minutes Clarifications
The U.S. Food and Drug Administration (FDA) has introduced a new pilot program aimed at enhancing communication with sponsors after…
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US / FDA updates on medical device regulation and quality.
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168 articles in US
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FDA Adds High-Profile Warning to Elevidys Label Amid Fatal Liver Injury Reports
The U.S. Food and Drug Administration (FDA) has approved a significant update to the labeling of Elevidys (delandistrogene moxeparvovec-rokl), a…
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FDA Issues Guidance on Unauthorized Anti-Choking Devices: Follow Proven Rescue Protocols
The Food and Drug Administration (FDA) has issued an important update encouraging the public to use established choking rescue methods…
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FDA Announces Appointment of Richard Pazdur as New CDER Director
The U.S. Food and Drug Administration (FDA) has confirmed that Dr. Richard Pazdur, a seasoned expert with 26 years of…
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HHS Updates Hormone Therapy Guidelines: Removing Misleading FDA Warnings for Women’s Health
The U.S. Department of Health and Human Services (HHS) has taken a pivotal step forward in supporting women’s health by…
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Fresenius Kabi Recalls Famotidine Injection Due to Elevated Endotoxin Levels in Reserve Samples
On November 6, 2025, Fresenius Kabi announced a voluntary nationwide recall of three lots of Famotidine Injection, USP, 20 mg…
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FDA Cracks Down on Illegal Marketing of Unapproved Botulinum Toxin Products
The U.S. Food and Drug Administration (FDA) has issued formal warnings to 18 website owners found marketing unapproved and misbranded…
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FDA Expands National Priority Voucher Program With Six New Awardees
The U.S. Food and Drug Administration (FDA) has announced six additional recipients of the Commissioner’s National Priority Voucher (CNPV) pilot…
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Olympus Updates Laser Bronchoscope Instructions Following Safety Concerns
Olympus Corporation has announced an important voluntary labeling update for bronchoscopes used with laser therapy, argon plasma coagulation, and high-frequency…
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Nationwide Recall of Mislabelled Potassium Chloride Injection – Critical FDA Update
Clinical professionals, regulatory teams, and healthcare providers should note the recent voluntary nationwide recall of a potassium chloride injection product.…
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FDA Moves to Halt Sale of Unapproved Fluoride Prescription Drugs for Children
The FDA has taken a significant step to protect children from unapproved ingestible fluoride prescription products. Announced on November 3,…
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Nationwide Recall Issued for Mislabelled Potassium Chloride Injection by Otsuka ICU Medical LLC
Otsuka ICU Medical LLC has announced a voluntary nationwide recall of a specific lot of potassium chloride injection due to…
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